Devices › Stimulator, spinal-cord, implanted (pain relief)
Device brand name · Scs lead
Exclaim 8: medical device reports filed with FDA
198 reports name it, 2012–2014. Manufacturer given most often on reports: St Jude Medical - Neuromodulation. Product code GZB.
- 198
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4%
- classified as malfunction
- 4.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 198 reports that name the brand "Exclaim 8" (scs lead), received between August 2012 and December 2014; the manufacturer given most often on reports is St Jude Medical - Neuromodulation. Spellings of one product vary from report to report.
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 (96%) and malfunction (4%); across all stimulator, spinal-cord, implanted (pain relief) reports (product code GZB) death is recorded in 0.4% and malfunction in 4.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (64.6%), impedance problem (27.8%) and high impedance (8.1%). The patient problems coded most often are inadequate pain relief, discomfort and fall. 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."
Reports by month, five years
No report naming Exclaim 8 was received in the five years to August 2026; the latest was received in December 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 43,947 reports carrying product code GZB. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 128 | 64.6% | 17.3% |
| Impedance problem | 55 | 27.8% | 5.7% |
| High impedance | 16 | 8.1% | 7.5% |
| Migration or expulsion of device | 16 | 8.1% | 3.7% |
| Therapy delivered to incorrect body area | 8 | 4% | 1.9% |
| Disconnection | 6 | 3% | 1.4% |
| Insufficient device problem information | 6 | 3% | 1.2% |
| Fracturea broken bone | 5 | 2.5% | 2.3% |
| Temperature problem | 4 | 2% | 4.5% |
| Torn material | 3 | 1.5% | 0% |
| Difficult to advance | 2 | 1% | 0.4% |
| Fluid/blood leak | 2 | 1% | 0.1% |
| Inappropriate/inadequate shock/stimulation | 2 | 1% | 0.8% |
| Detachment of device component | 1 | 0.5% | 0.1% |
| Device stops intermittentlythe device stopped now and then | 1 | 0.5% | 0.4% |
| Invalid sensing | 1 | 0.5% | 0% |
| Knotted | 1 | 0.5% | 0% |
| Low impedance | 1 | 0.5% | 2% |
| No device output | 1 | 0.5% | 3% |
| Shelf life exceeded | 1 | 0.5% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Inadequate pain relief | 150 | 75.8% |
| Discomfortdiscomfort | 11 | 5.6% |
| Falla fall | 11 | 5.6% |
| Therapeutic effects, unexpected | 11 | 5.6% |
| Painpain, site not specified | 9 | 4.5% |
| Burning sensationa burning feeling | 5 | 2.5% |
| Device overstimulation of tissue | 5 | 2.5% |
| Neck painneck pain | 4 | 2% |
| Post operative wound infection | 4 | 2% |
| Cerebrospinal fluid leakage | 2 | 1% |
| Headachehead pain | 2 | 1% |
| Headache, lumbar puncture | 2 | 1% |
| Injurya physical injury | 2 | 1% |
| Numbnessnumbness | 2 | 1% |
| Shock from patient lead(s) | 2 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Exclaim 8 | Product code GZB | All MAUDE reports |
|---|---|---|---|
| Reports | 198 | 43,947 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 96% | 94.3% | 36.2% |
| Classified as malfunction | 4% | 4.1% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 94.9% |
Shares are of reports, not 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."
Other brands with product code GZB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Octrode Lead Kit, 60cm Length | 47,037 | 5,133 | 0.1% |
| Octrode | 8,403 | 0 | 0.1% |
| Eon Mini | 9,122 | 0 | 0.6% |
| Penta 3mm Lead, 60 cm | 9,617 | 839 | 0.3% |
| Eon Mini IPG, 16-Channel Rechargeable | 14,176 | 111 | 0.2% |
| Swift-Lock Anchor | 2,396 | 206 | 0% |
| Penta | 2,532 | 0 | 0.1% |
| Octrode Trial Lead Kit, 60cm Length | 2,790 | 71 | 1.4% |
| Quattrode | 2,208 | 0 | 0% |
| Octrode Lead Kit, 90cm Length | 3,742 | 329 | 0.2% |
| Eon | 2,381 | 0 | 0.8% |
| Charging System | 2,823 | 0 | 0% |
| SureScan | 33,123 | 490 | 0% |
| Lamitrode S-8 Lead Kit, 60cm Length | 1,267 | 41 | 0.1% |
| Lamitrode Tripole 16 Lead, 60 cm | 1,448 | 83 | 0.3% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Exclaim 8 reports
How many FDA reports name Exclaim 8?
198 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (96%) and malfunction (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (64.6%), impedance problem (27.8%), high impedance (8.1%), migration or expulsion of device (8.1%) and therapy delivered to incorrect body area (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Exclaim 8 was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.