Device manufacturer, as written on reports

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

98,256 reports name it as the manufacturer of the device involved, 2010–2020.

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.

98,256
reports naming it as manufacturer: 0.4% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 9.3%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

98,256 medical device reports received by FDA give St Jude Medical - Neuromodulation as the manufacturer of the device involved, 0.4% of the MAUDE database, from June 2010 to October 2020. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (90.2%), malfunction (9.3%) and death (0.3%). 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
Eon Mini IPG, 16-Channel Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	10,865	111	0.2%
Octrode Lead Kit, 60cm Length	Stimulator, spinal-cord, totally implanted for pain relief	10,602	5,133	0.1%
Eon Mini	Stimulator, spinal-cord, totally implanted for pain relief	7,877	0	0.6%
Octrode	Stimulator, spinal-cord, implanted (pain relief)	7,092	0	0.1%
Penta 3mm Lead, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	4,860	839	0.3%
Proclaim 5 Elite	Stimulator, spinal-cord, totally implanted for pain relief	4,149	0	0.2%
Proclaim 7 Elite	Stimulator, spinal-cord, totally implanted for pain relief	3,419	0	0.5%
Charging System	Stimulator, spinal-cord, totally implanted for pain relief	2,493	0	0%
Eon Rechargeable IPG, 16-Channel	Stimulator, spinal-cord, totally implanted for pain relief	2,187	26	0.6%
Penta	Stimulator, spinal-cord, totally implanted for pain relief	2,165	0	0.1%
Eon	Stimulator, spinal-cord, totally implanted for pain relief	2,024	0	0.8%
50cm Implant Lead Kit Slim Tip	Dorsal root ganglion stimulator for pain relief	1,983	0	0.1%
Quattrode	Stimulator, spinal-cord, implanted (pain relief)	1,896	0	0%
Octrode Lead Kit, 90cm Length	Stimulator, spinal-cord, totally implanted for pain relief	1,866	329	0.2%
Quattrode Lead Wide Spaced, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	1,285	143	0.1%
Kit Implantable Slim Tip Lead, 50cm	Dorsal root ganglion stimulator for pain relief	1,268	1,417	0.1%
Proclaim 5 Elite Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	1,216	2,057	0.1%
Swift-Lock Anchor	Stimulator, spinal-cord, implanted (pain relief)	1,182	206	0%
Proclaim 7 Elite Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	1,113	333	0.1%
Protege IPG, 16-Channel Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	1,105	69	0.3%
Lamitrode Tripole 16 Lead, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	995	83	0.3%
Lamitrode S-8 Lead Kit, 60cm Length	Stimulator, spinal-cord, totally implanted for pain relief	943	41	0.1%
Quattrode Lead Wide Spaced, 90 cm	Stimulator, peripheral nerve, implanted (pain relief)	904	25	0%
Extension, 30cm	Stimulator, spinal-cord, totally implanted for pain relief	736	31	0.2%
Lamitrode Tripole 16	Stimulator, spinal-cord, totally implanted for pain relief	735	0	0.5%
8CH Infinity DBS Lead Kit, 40cm, 0.5, B	Stimulator, electrical, implanted, for parkinsonian tremor	710	92	1.3%
Eon C 16-Channel Ipg	Stimulator, spinal-cord, totally implanted for pain relief	679	2	0.5%
Lamitrode S8	Stimulator, spinal-cord, implanted (pain relief)	659	0	0.4%
Octrode Trial Lead Kit, 60cm Length	Stimulator, spinal-cord, totally implanted for pain relief	641	71	1.4%
90cm Implant Lead Kit Slim Tip	Dorsal root ganglion stimulator for pain relief	496	0	0.7%

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	56,111	57.1%
GZB	Stimulator, spinal-cord, implanted (pain relief)	32,348	32.9%
PMP	Dorsal root ganglion stimulator for pain relief	6,122	6.2%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	1,918	2%
GZF	Stimulator, peripheral nerve, implanted (pain relief)	1,676	1.7%
LWS	Implantable cardioverter defibrillator (non-crt)	17	0%
GBZ	Catheter, cholangiography	8	0%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	5	0%
DTB	Permanent pacemaker electrode	3	0%
GXY	Electrode, cutaneous	2	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

Death0.3%309

Injury90.2%88,667

Malfunction9.3%9,105

Other0.1%146

Not given0%29

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 reports

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

98,256 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Eon Mini IPG, 16-Channel Rechargeable (10,865), Octrode Lead Kit, 60cm Length (10,602), Eon Mini (7,877), Octrode (7,092) and Penta 3mm Lead, 60 cm (4,860).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (57.1%), stimulator, spinal-cord, implanted (pain relief) (32.9%), dorsal root ganglion stimulator for pain relief (6.2%) and stimulator, electrical, implanted, for parkinsonian tremor (2%).

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.