Device manufacturer, as written on reports
St Jude Medical - Neuromodulation Division: medical device reports filed with FDA
1,235 reports name it as the manufacturer of the device involved, 2010–2015.
- 1,235
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 25.8%
- classified as malfunction
- 62.3% across all reports
- 0.6%
- classified as death, as reported
- 0.9% across all reports
1,235 medical device reports received by FDA give St Jude Medical - Neuromodulation Division as the manufacturer of the device involved, 0% of the MAUDE database, from October 2010 to October 2015. 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 (72.8%), malfunction (25.8%) and other (0.6%). 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 Percutaneous Lead | Stimulator, spinal-cord, totally implanted for pain relief | 145 | 0 | 0.6% |
| Eon Mini Rechargeable Ipg | Stimulator, spinal-cord, totally implanted for pain relief | 110 | 0 | 0% |
| Eon Mini IPG, 16-Channel Rechargeable | Stimulator, spinal-cord, totally implanted for pain relief | 94 | 111 | 0.2% |
| Octrode Lead Kit, 60cm Length | Stimulator, spinal-cord, totally implanted for pain relief | 75 | 5,133 | 0.1% |
| Eon Rechargeable Ipg | Stimulator, spinal-cord, totally implanted for pain relief | 67 | 0 | 0.5% |
| Eon Mini Ipg | Stimulator, spinal-cord, totally implanted for pain relief | 60 | 0 | 0.5% |
| Eon Rechargeable IPG, 16-Channel | Stimulator, spinal-cord, totally implanted for pain relief | 58 | 26 | 0.6% |
| Penta 3mm Lead, 60 cm | Stimulator, spinal-cord, totally implanted for pain relief | 26 | 839 | 0.3% |
| Quattrode Percutaneous Lead | Stimulator, spinal-cord, totally implanted for pain relief | 26 | 0 | 0% |
| Genesis Pulse Generator 8-Channel | Stimulator, spinal-cord, totally implanted for pain relief | 19 | 0 | 0% |
| Eon C 16-Channel Ipg | Stimulator, spinal-cord, totally implanted for pain relief | 18 | 2 | 0.5% |
| Single Extension | Stimulator, spinal-cord, implanted (pain relief) | 16 | 0 | 0% |
| Swift-Lock Anchor | Stimulator, spinal-cord, implanted (pain relief) | 16 | 206 | 0% |
| Eon Mini 16-Channel Ipg | Stimulator, spinal-cord, totally implanted for pain relief | 15 | 0 | 0.8% |
| Lamitrode Tripole 16 Lead, 60 cm | Stimulator, spinal-cord, totally implanted for pain relief | 13 | 83 | 0.3% |
| Dual Extension | Stimulator, spinal-cord, totally implanted for pain relief | 12 | 0 | 0% |
| Eon Mini | Stimulator, spinal-cord, totally implanted for pain relief | 7 | 0 | 0.6% |
| Octrode Trial Lead Kit, 60cm Length | Stimulator, spinal-cord, totally implanted for pain relief | 7 | 71 | 1.4% |
| Eon 16-Channel Ipg | Stimulator, spinal-cord, totally implanted for pain relief | 6 | 0 | 1.6% |
| Extension, 30cm | Stimulator, spinal-cord, totally implanted for pain relief | 6 | 31 | 0.2% |
| Quattrode Lead Wide Spaced, 60 cm | Stimulator, spinal-cord, totally implanted for pain relief | 6 | 143 | 0.1% |
| Cinch Lead Anchor | Stimulator, spinal-cord, implanted (pain relief) | 5 | 24 | 0% |
| Lamitrode Tripole 16c Lead 60 Cm | Stimulator, spinal-cord, totally implanted for pain relief | 4 | 14 | 0.3% |
| Octrode | Stimulator, spinal-cord, implanted (pain relief) | 4 | 0 | 0.1% |
| Charging System | Stimulator, spinal-cord, totally implanted for pain relief | 3 | 0 | 0% |
| Octrode Lead Kit, 90cm Length | Stimulator, spinal-cord, totally implanted for pain relief | 3 | 329 | 0.2% |
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 | 1,129 | 91.4% |
| GZB | Stimulator, spinal-cord, implanted (pain relief) | 104 | 8.4% |
| HXC | Wrench | 1 | 0.1% |
| LWS | Implantable cardioverter defibrillator (non-crt) | 1 | 0.1% |
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
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 Division reports
How many FDA device reports name St Jude Medical - Neuromodulation Division as manufacturer?
1,235 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Octrode Percutaneous Lead (145), Eon Mini Rechargeable Ipg (110), Eon Mini IPG, 16-Channel Rechargeable (94), Octrode Lead Kit, 60cm Length (75) and Eon Rechargeable Ipg (67).
Which device types does it report on?
stimulator, spinal-cord, totally implanted for pain relief (91.4%), stimulator, spinal-cord, implanted (pain relief) (8.4%), wrench (0.1%) and implantable cardioverter defibrillator (non-crt) (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.