Device manufacturer, as written on reports

Boston Scientific Neuromodulation: medical device reports filed with FDA

84,008 reports name it as the manufacturer of the device involved, 2008–2026.

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.

84,008
reports naming it as manufacturer: 0.3% of all MAUDE reports; 9,942
reports, 12 months to August 2026: 8,631 in the 12 months before; 9.1%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

84,008 medical device reports received by FDA give Boston Scientific Neuromodulation as the manufacturer of the device involved, 0.3% of the MAUDE database, from January 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

9,942 reports arrived in the 12 months to August 2026, up 15% from 8,631 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 (90.3%), malfunction (9.1%) and death (0.5%). 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
Precision?	Stimulator, spinal-cord, totally implanted for pain relief	24,649	446	0.4%
Precision Spectra ?	Stimulator, spinal-cord, totally implanted for pain relief	16,816	971	0.5%
Spectra WaveWriter?	Stimulator, spinal-cord, totally implanted for pain relief	7,750	1,093	0.4%
WaveWriter Alpha?	Stimulator, spinal-cord, totally implanted for pain relief	4,956	1,591	0.9%
Precision? Montage? MRI	Stimulator, spinal-cord, totally implanted for pain relief	4,753	786	0.3%
Linear? ST	Stimulator, spinal-cord, totally implanted for pain relief	4,091	702	0.1%
WaveWriter Alpha? 16	Stimulator, spinal-cord, totally implanted for pain relief	2,567	879	0.8%
Infinion? CX	Stimulator, spinal-cord, totally implanted for pain relief	2,258	280	0%
Superion Indirect Decompression System	Prosthesis, spinous process spacer/plate	1,622	592	0%
Infinion 16	Stimulator, spinal-cord, totally implanted for pain relief	1,370	234	1.1%
CoverEdge? 32	Stimulator, spinal-cord, totally implanted for pain relief	1,169	169	0.1%
WaveWriter Alpha? Prime	Stimulator, spinal-cord, totally implanted for pain relief	1,120	400	0.7%
Precision Novi?	Stimulator, spinal-cord, totally implanted for pain relief	1,110	72	1.3%
WaveWriter Alpha? Prime 16	Stimulator, spinal-cord, totally implanted for pain relief	1,100	435	1.5%
Vercise Genus	Stimulator, electrical, implanted, for parkinsonian symptoms	1,014	338	2.4%
Artisan?	Stimulator, spinal-cord, totally implanted for pain relief	912	127	0.6%
Vercise? Cartesia?	Stimulator, electrical, implanted, for parkinsonian symptoms	907	132	2.4%
Linear? 3-4	Stimulator, spinal-cord, totally implanted for pain relief	587	89	0.2%
Avista? MRI	Stimulator, spinal-cord, totally implanted for pain relief	568	81	0%
Vercise Gevia?	Stimulator, electrical, implanted, for parkinsonian tremor	352	26	2.3%
Linear? 3-6	Stimulator, spinal-cord, totally implanted for pain relief	336	12	0.3%
Vercise	Stimulator, electrical, implanted, for parkinsonian tremor	270	43	0.4%
Ni	Set, administration, for peritoneal dialysis, disposable	199	1,587	1.8%
Artisan? MRI	Stimulator, spinal-cord, totally implanted for pain relief	185	13	0%
Linear	Stimulator, spinal-cord, totally implanted for pain relief	161	14	0%
Superion Interspinous Spacer	Prosthesis, spinous process spacer/plate	152	18	0.4%
SureTek?	Stimulator, electrical, implanted, for parkinsonian tremor	147	31	0%
Vercise Pc	Stimulator, electrical, implanted, for parkinsonian tremor	147	15	1.3%
Spectra	Stimulator, spinal-cord, totally implanted for pain relief	120	8	3%
Boston Scientific	Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass	1	5	3.3%

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	78,568	93.5%
NQO	Prosthesis, spinous process spacer/plate	1,917	2.3%
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms	1,779	2.1%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	1,450	1.7%
PJS	Stimulator, electrical, implanted, for essential tremor	154	0.2%
GXI	Probe, radiofrequency lesion	149	0.2%
GXD	Generator, lesion, radiofrequency	22	0%
GZB	Stimulator, spinal-cord, implanted (pain relief)	4	0%
GAT	Suture, nonabsorbable, synthetic, polyethylene	2	0%
LWP	Implantable pulse generator, pacemaker (non-crt)	1	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

Death0.5%462

Injury90.3%75,859

Malfunction9.1%7,683

Other0%2

Not given0%2

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

Questions about Boston Scientific Neuromodulation reports

How many FDA device reports name Boston Scientific Neuromodulation as manufacturer?

84,008 reports through August 2026, 9,942 of them in the latest 12 months.

Which of its brands appear most often?

Precision? (24,649), Precision Spectra ? (16,816), Spectra WaveWriter? (7,750), WaveWriter Alpha? (4,956) and Precision? Montage? MRI (4,753).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (93.5%), prosthesis, spinous process spacer/plate (2.3%), stimulator, electrical, implanted, for parkinsonian symptoms (2.1%) and stimulator, electrical, implanted, for parkinsonian tremor (1.7%).

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.