Device manufacturer, as written on reports

St Jude Medical - Neuromodulation Puerto Rico: medical device reports filed with FDA

63,993 reports name it as the manufacturer of the device involved, 2014–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

63,993
reports naming it as manufacturer: 0.2% of all MAUDE reports; 8,296
reports, 12 months to August 2026: 9,546 in the 12 months before; 2.1%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

63,993 medical device reports received by FDA give St Jude Medical - Neuromodulation Puerto Rico as the manufacturer of the device involved, 0.2% of the MAUDE database, from December 2014 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

8,296 reports arrived in the 12 months to August 2026, down 13% from 9,546 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (97.6%), malfunction (2.1%) and death (0.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Octrode Lead Kit, 60cm Length	Stimulator, spinal-cord, totally implanted for pain relief	31,750	5,133	0.1%
Proclaim 5 Elite Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	16,166	2,057	0.1%
Prodigy MRI IPG, 16CH, Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	2,454	396	0%
Prot G Mri Ipg	Stimulator, spinal-cord, totally implanted for pain relief	2,171	102	0.2%
Octrode Trial Lead Kit, 60cm Length	Stimulator, spinal-cord, totally implanted for pain relief	2,004	71	1.4%
Penta 3mm Lead, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	1,606	839	0.3%
Proclaim 7 Elite Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	1,561	333	0.1%
Protege IPG, 16-Channel Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	1,488	69	0.3%
Proclaim Plus Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	1,353	663	0.1%
Proclaim 5 Elite	Stimulator, spinal-cord, totally implanted for pain relief	670	0	0.2%
Prodigy Mri Ipg	Stimulator, spinal-cord, totally implanted for pain relief	557	0	0.1%
Eon Mini IPG, 16-Channel Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	498	111	0.2%
Protege Mri Ipg	Stimulator, spinal-cord, totally implanted for pain relief	468	0	0%
Infinity 7 Implantable Pulse Generator	Stimulator, electrical, implanted, for parkinsonian tremor	224	147	0.5%
Proclaim 7 Elite	Stimulator, spinal-cord, totally implanted for pain relief	158	0	0.5%
Lamitrode TriCentrus 16 Lead, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	144	79	0%
Extension, 30cm	Stimulator, spinal-cord, totally implanted for pain relief	72	31	0.2%
Lamitrode Tripole 16 Lead, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	55	83	0.3%
Extension, 60cm	Stimulator, spinal-cord, totally implanted for pain relief	36	18	0%
Tendril Sts	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	25	4,320	3.1%
Infinity 5 Implantable Pulse Generator	Stimulator, electrical, implanted, for parkinsonian tremor	24	22	0.6%
Durata Sts Optim Active Fixation Df-4 Connector	Permanent defibrillator electrodes	22	1,784	3.9%
Quadra Assura Crt-D Quad Rf Hv	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	16	14	2.5%
Quartet	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	13	848	5.2%
Quadra Assura MP ICD	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	11	507	2.1%
Kit Implantable Slim Tip Lead, 50cm	Dorsal root ganglion stimulator for pain relief	10	1,417	0.1%
Optisure Active Fixation Df-4 Connector	Permanent defibrillator electrodes	8	623	4.3%
Assurity Mri	Implantable pulse generator, pacemaker (non-crt)	7	2,035	1.8%
Octrode Lead Kit, 90cm Length	Stimulator, spinal-cord, totally implanted for pain relief	6	329	0.2%
Quadra Assura Ddqp+	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	5	0	2.3%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
LGW	Stimulator, spinal-cord, totally implanted for pain relief	59,725	93.3%
GZB	Stimulator, spinal-cord, implanted (pain relief)	3,818	6%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	250	0.4%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	49	0.1%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	31	0%
NVY	Permanent defibrillator electrodes	31	0%
PMP	Dorsal root ganglion stimulator for pain relief	19	0%
LWP	Implantable pulse generator, pacemaker (non-crt)	18	0%
LWS	Implantable cardioverter defibrillator (non-crt)	17	0%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	17	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.2%132

Injury97.6%62,479

Malfunction2.1%1,375

Other0%6

Not given0%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about St Jude Medical - Neuromodulation Puerto Rico reports

How many FDA device reports name St Jude Medical - Neuromodulation Puerto Rico as manufacturer?

63,993 reports through August 2026, 8,296 of them in the latest 12 months.

Which of its brands appear most often?

Octrode Lead Kit, 60cm Length (31,750), Proclaim 5 Elite Implantable Pulse Generator (16,166), Prodigy MRI IPG, 16CH, Rechargeable (2,454), Prot G Mri Ipg (2,171) and Octrode Trial Lead Kit, 60cm Length (2,004).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (93.3%), stimulator, spinal-cord, implanted (pain relief) (6%), stimulator, electrical, implanted, for parkinsonian tremor (0.4%) and defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (0.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.