Devices › Implantable cardioverter defibrillator (non-crt)
Device brand name · Implantable tachy lead
Sprint Fidelis: medical device reports filed with FDA
17,005 reports name it, 2005–2026. Manufacturer given most often on reports: Medtronic Puerto Rico. Product code LWS.
- 17,005
- device reports naming the brand
- 0.1% of all MAUDE reports · about 791 a year
- 340
- reports, 12 months to August 2026
- 398 in the 12 months before
- 12.3%
- classified as malfunction
- 37.4% across the product code
- 14.1%
- classified as death, as reported
- 2,392 reports · not verified by FDA
17,005 medical device reports received by FDA name the brand "Sprint Fidelis" (implantable tachy lead); the manufacturer given most often on reports is Medtronic Puerto Rico; received from January 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
340 reports arrived in the 12 months to August 2026, down 15% from 398 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 (73.2%), death (14.1%) and malfunction (12.3%); 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 high impedance (29.6%), over-sensing (29.5%) and inappropriate/inadequate shock/stimulation (22.2%). The patient problems coded most often are death, shock from patient lead(s) and distress. 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 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 |
|---|---|---|---|
| High impedance | 5,033 | 29.6% | 15.6% |
| Over-sensing | 5,012 | 29.5% | 21.1% |
| Inappropriate/inadequate shock/stimulation | 3,782 | 22.2% | 12.8% |
| Fracturea broken bone | 3,735 | 22% | 5.8% |
| Lead(s), fracture of | 2,051 | 12.1% | 1.1% |
| Signal artifact/noise | 1,940 | 11.4% | 8% |
| Impedance problem | 1,852 | 10.9% | 4.4% |
| Nonstandard device | 1,341 | 7.9% | 1.1% |
| High capture threshold | 943 | 5.5% | 3.6% |
| Defective devicethe device was defective | 851 | 5% | 1.3% |
| Interference | 777 | 4.6% | 0.4% |
| Under-sensing | 605 | 3.6% | 3.1% |
| Failure to capture | 585 | 3.4% | 2.6% |
| High sensing threshold | 564 | 3.3% | 0.8% |
| Capturing problem | 452 | 2.7% | 1.5% |
| Breakthe device broke | 430 | 2.5% | 1% |
| Device remains activated | 412 | 2.4% | 0.5% |
| Low impedance | 361 | 2.1% | 2.8% |
| Device sensing problem | 286 | 1.7% | 3.9% |
| Other (for use when an appropriate device code cannot be identified) | 206 | 1.2% | 0.6% |
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 | 2,367 | 13.9% |
| Shock from patient lead(s) | 1,423 | 8.4% |
| Distress | 296 | 1.7% |
| Anxietyanxiety | 236 | 1.4% |
| Depressionlow mood | 211 | 1.2% |
| Painpain, site not specified | 176 | 1% |
| Emotional changes | 135 | 0.8% |
| Syncopefainting | 114 | 0.7% |
| Injurya physical injury | 105 | 0.6% |
| Dizzinesslight-headedness or unsteadiness | 81 | 0.5% |
| Electric shockan electric shock | 79 | 0.5% |
| Failure of implant | 70 | 0.4% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 63 | 0.4% |
| Endocarditis | 60 | 0.4% |
| Internal organ perforation | 57 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sprint Fidelis | Product code LWS | All MAUDE reports |
|---|---|---|---|
| Reports | 17,005 | 380,959 | 26,136,888 |
| Share of that pool | — | 4.5% | 0.1% |
| Classified as death, per 1,000 reports | 141 | 27 | 9 |
| Classified as injury | 73.2% | 59.6% | 36.2% |
| Classified as malfunction | 12.3% | 37.4% | 62.3% |
| Filed by the manufacturer | 97.6% | 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 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% |
| S-Icd System | 5,104 | 0 | 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 Sprint Fidelis reports
How many FDA reports name Sprint Fidelis?
17,005 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 340 in the latest 12 months.
What kinds of events are reported?
injury (73.2%), death (14.1%) and malfunction (12.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high impedance (29.6%), over-sensing (29.5%), inappropriate/inadequate shock/stimulation (22.2%), fracture (22%) and lead(s), fracture of (12.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.6%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sprint Fidelis 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.