Devices › Permanent pacemaker electrode
Device brand name · Implantable pacing lead
Spectraflex: medical device reports filed with FDA
609 reports name it, 1997–2025. Manufacturer given most often on reports: Medtronic Puerto Rico. Product code DTB.
- 609
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 0
- reports, 12 months to August 2026
- 11 in the 12 months before
- 30%
- classified as malfunction
- 43.9% across the product code
- 4.9%
- classified as death, as reported
- 30 reports · not verified by FDA
609 medical device reports received by FDA name the brand "Spectraflex" (implantable pacing lead); the manufacturer given most often on reports is Medtronic Puerto Rico; received from February 1997 to August 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 11 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 (64.7%), malfunction (30%) and death (4.9%); across all permanent pacemaker electrode reports (product code DTB) death is recorded in 2.9% and malfunction in 43.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to capture (10.7%), lead(s), fracture of (9.5%) and low impedance (9.4%). The patient problems coded most often are death, muscle stimulation and syncope. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 327,317 reports carrying product code DTB. 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 |
|---|---|---|---|
| Failure to capture | 65 | 10.7% | 9.7% |
| Lead(s), fracture of | 58 | 9.5% | 0.9% |
| Low impedance | 57 | 9.4% | 5.3% |
| High capture threshold | 37 | 6.1% | 12.3% |
| High sensing threshold | 36 | 5.9% | 2.3% |
| Over-sensing | 34 | 5.6% | 13.2% |
| Under-sensing | 34 | 5.6% | 17.1% |
| Fracturea broken bone | 32 | 5.3% | 4.8% |
| Other (for use when an appropriate device code cannot be identified) | 32 | 5.3% | 0.5% |
| High impedance | 31 | 5.1% | 10.7% |
| Insulation, hole(s) in | 25 | 4.1% | 0.2% |
| Loss of threshold | 24 | 3.9% | 0.7% |
| Performance | 22 | 3.6% | 0.1% |
| Breakthe device broke | 18 | 3% | 1.8% |
| Capturing problem | 18 | 3% | 4.2% |
| Signal artifact/noise | 18 | 3% | 5.2% |
| Impedance problem | 16 | 2.6% | 4.3% |
| Device issuea problem with the device | 12 | 2% | 0.1% |
| Failure to sense | 11 | 1.8% | 1% |
| Pacing problem | 11 | 1.8% | 5% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 33 | 5.4% |
| Muscle stimulation | 17 | 2.8% |
| Syncopefainting | 6 | 1% |
| Bradycardiaslow heart rate | 5 | 0.8% |
| Dizzinesslight-headedness or unsteadiness | 5 | 0.8% |
| Discomfortdiscomfort | 4 | 0.7% |
| Arrhythmia | 2 | 0.3% |
| Atrial fibrillationan irregular heart rhythm | 2 | 0.3% |
| Device overstimulation of tissue | 2 | 0.3% |
| Fainting | 2 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.3% |
| Hypersensitivity/allergic reaction | 2 | 0.3% |
| Palpitationsawareness of the heartbeat | 2 | 0.3% |
| Sepsisa severe body-wide response to infection | 2 | 0.3% |
| Surgical procedure | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Spectraflex | Product code DTB | All MAUDE reports |
|---|---|---|---|
| Reports | 609 | 327,317 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 49 | 29 | 9 |
| Classified as injury | 64.7% | 53.1% | 36.2% |
| Classified as malfunction | 30% | 43.9% | 62.3% |
| Filed by the manufacturer | 99.8% | 96.8% | 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 DTB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CapSureFix Novus Lead MRI SureScan | 108,103 | 17,554 | 1% |
| Capsurefix Novus | 57,538 | 4 | 6.8% |
| CapSureFix Novus MRI SureScan | 18,909 | 3,243 | 1.3% |
| CapSure Sense Lead MRI SureScan | 8,774 | 1,337 | 1% |
| CapSure SP | 8,223 | 226 | 3.9% |
| Capsurefix | 7,284 | 0 | 6.3% |
| Permanent Pacemaker Electrode | 5,041 | 332 | 0.4% |
| Capsure Sp Novus | 4,803 | 0 | 9.5% |
| Capsure Sense | 4,740 | 0 | 6.4% |
| Flextend | 6,836 | 203 | 0.7% |
| Attain Otw | 7,773 | 0 | 9.1% |
| Tendril Sdx | 8,316 | 3 | 2.3% |
| CapSure Epicardial Lead | 4,842 | 760 | 1.5% |
| Tendril Sts | 54,036 | 4,320 | 3.1% |
| CapSure SP Novus Lead | 2,715 | 331 | 1.1% |
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 Spectraflex reports
How many FDA reports name Spectraflex?
609 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 (64.7%), malfunction (30%) and death (4.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to capture (10.7%), lead(s), fracture of (9.5%), low impedance (9.4%), high capture threshold (6.1%) and high sensing threshold (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Spectraflex 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.