Devices › Implantable cardioverter defibrillator (non-crt)
Device brand name · Transvenous defibrillation lead
Endotak Down-Sized Plus: medical device reports filed with FDA
227 reports name it, 1997–1997. Manufacturer given most often on reports: Cardiac Pacemakers. Product code LWS.
- 227
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 12.8%
- classified as malfunction
- 37.4% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 227 reports that name the brand "Endotak Down-Sized Plus" (transvenous defibrillation lead), received between January 1997 and November 1997; the manufacturer given most often on reports is Cardiac Pacemakers. 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 (86.8%), malfunction (12.8%) and death (0.4%); across all implantable cardioverter defibrillator (non-crt) reports (product code LWS) death is recorded in 2.7% and malfunction in 37.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device damaged prior to use (41.4%), over-sensing (26.9%) and inappropriate/inadequate shock/stimulation (22.9%). The patient problems coded most often are other (for use when an appropriate patient code cannot be identified), twiddlers syndrome and ventricular fibrillation. 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 Endotak Down-Sized Plus was received in the five years to August 2026; the latest was received in November 1997.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 380,959 reports carrying product code LWS. 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 damaged prior to usethe device was damaged before use | 94 | 41.4% | 0.8% |
| Over-sensing | 61 | 26.9% | 21.1% |
| Inappropriate/inadequate shock/stimulation | 52 | 22.9% | 12.8% |
| Normal | 48 | 21.1% | 1.8% |
| High impedance | 28 | 12.3% | 15.6% |
| Dislodged | 19 | 8.4% | 0.7% |
| Sensing intermittently | 18 | 7.9% | 0.2% |
| Loss of threshold | 13 | 5.7% | 0.4% |
| Failure to capture | 10 | 4.4% | 2.6% |
| Low readingsreadings were too low | 5 | 2.2% | 0.2% |
| Under-sensing | 3 | 1.3% | 3.1% |
| Difficult to position | 2 | 0.9% | 0.3% |
| Performance | 2 | 0.9% | 0.2% |
| Alarm, error of warning | 1 | 0.4% | 0.5% |
| Connection error | 1 | 0.4% | 0.1% |
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 |
|---|---|---|
| Other (for use when an appropriate patient code cannot be identified) | 4 | 1.8% |
| Twiddlers syndrome | 3 | 1.3% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 2 | 0.9% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 2 | 0.9% |
| Bradycardiaslow heart rate | 1 | 0.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.4% |
| Perforation | 1 | 0.4% |
| Pocket erosion | 1 | 0.4% |
| Syncopefainting | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endotak Down-Sized Plus | Product code LWS | All MAUDE reports |
|---|---|---|---|
| Reports | 227 | 380,959 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 4 | 27 | 9 |
| Classified as injury | 86.8% | 59.6% | 36.2% |
| Classified as malfunction | 12.8% | 37.4% | 62.3% |
| Filed by the manufacturer | 100% | 97.8% | 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 LWS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sprint Quattro Secure S MRI SureScan | 36,895 | 6,436 | 1.4% |
| Emblem Mri S-Icd | 21,480 | 3,088 | 0.2% |
| Sprint Quattro Secure | 24,237 | 2 | 5.2% |
| Emblem S-Icd | 17,250 | 2,237 | 0.1% |
| Sprint Fidelis | 17,005 | 340 | 14.1% |
| Sprint Quattro Secure S | 14,398 | 0 | 2.4% |
| Endotak Reliance | 25,897 | 238 | 1.2% |
| Sprint Quattro Secure MRI SureScan | 15,606 | 1,903 | 1.4% |
| Endotak Reliance G | 10,115 | 1,049 | 0.6% |
| Teligen | 16,537 | 47 | 0.6% |
| Durata Sts Optim Active Fixation | 9,681 | 301 | 5.6% |
| Sprint Quattro | 5,591 | 0 | 2.6% |
| Reliance 4-Front | 9,852 | 2,024 | 0.4% |
| Sprint | 6,131 | 161 | 2.4% |
| Vitality 2 | 4,779 | 0 | 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 Endotak Down-Sized Plus reports
How many FDA reports name Endotak Down-Sized Plus?
227 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 (86.8%), malfunction (12.8%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device damaged prior to use (41.4%), over-sensing (26.9%), inappropriate/inadequate shock/stimulation (22.9%), normal (21.1%) and high impedance (12.3%). 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 Endotak Down-Sized Plus 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.