Devices › Pulse generator, permanent, implantable
Device brand name · Implantable cardioverter defibrillator
Fortify Vr U1 6 Sj4 Us: medical device reports filed with FDA
1,564 reports name it, 2015–2026. Manufacturer given most often on reports: St Jude Medical Crm-Sylmar. Product code NVZ.
- 1,564
- device reports naming the brand
- 0% of all MAUDE reports · about 140 a year
- 8
- reports, 12 months to August 2026
- 3 in the 12 months before
- 11.1%
- classified as malfunction
- 43.5% across the product code
- 1.2%
- classified as death, as reported
- 19 reports · not verified by FDA
1,564 medical device reports received by FDA name the brand "Fortify Vr U1 6 Sj4 Us" (implantable cardioverter defibrillator); the manufacturer given most often on reports is St Jude Medical Crm-Sylmar; received from May 2015 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
8 reports arrived in the 12 months to August 2026, up 167% from 3 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 (87.7%), malfunction (11.1%) and death (1.2%); across all pulse generator, permanent, implantable reports (product code NVZ) death is recorded in 4.1% and malfunction in 43.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are battery problem (29.3%), premature discharge of battery (24.8%) and failure to interrogate (8.8%). The patient problems coded most often are shock from patient lead(s), therapeutic effects, unexpected and death. 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 95,612 reports carrying product code NVZ. 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 |
|---|---|---|---|
| Battery problema problem with the battery | 459 | 29.3% | 4.7% |
| Premature discharge of battery | 388 | 24.8% | 11.3% |
| Failure to interrogate | 138 | 8.8% | 4.6% |
| Inappropriate/inadequate shock/stimulation | 106 | 6.8% | 1.4% |
| Over-sensing | 54 | 3.5% | 5.6% |
| Premature elective replacement indicator | 46 | 2.9% | 0.8% |
| Inappropriate or unexpected reset | 35 | 2.2% | 1.9% |
| Incorrect interpretation of signal | 18 | 1.2% | 0.6% |
| Defective devicethe device was defective | 17 | 1.1% | 1.4% |
| Delayed charge time | 16 | 1% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 13 | 0.8% | 1.3% |
| Premature end-of-life indicator | 12 | 0.8% | 0.1% |
| Signal artifact/noise | 10 | 0.6% | 1.2% |
| High impedance | 9 | 0.6% | 1.7% |
| Output problem | 9 | 0.6% | 0.6% |
| Difficult to interrogate | 7 | 0.4% | 0.2% |
| Data problem | 6 | 0.4% | 0.8% |
| Defibrillation/stimulation problem | 6 | 0.4% | 0% |
| Failure to charge | 6 | 0.4% | 0.2% |
| Incorrect measurementthe device measured wrongly | 6 | 0.4% | 1.6% |
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 |
|---|---|---|
| Shock from patient lead(s) | 46 | 2.9% |
| Therapeutic effects, unexpected | 38 | 2.4% |
| Deaththe patient died; cause not stated by this term | 21 | 1.3% |
| Device overstimulation of tissue | 18 | 1.2% |
| Discomfortdiscomfort | 15 | 1% |
| Dizzinesslight-headedness or unsteadiness | 7 | 0.4% |
| Arrhythmia | 6 | 0.4% |
| Fainting | 5 | 0.3% |
| Syncopefainting | 5 | 0.3% |
| Dyspneashortness of breath | 4 | 0.3% |
| Cardiac arrestthe heart stopped | 3 | 0.2% |
| Chest painchest pain | 3 | 0.2% |
| Falla fall | 3 | 0.2% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 3 | 0.2% |
| Complaint, ill-defined | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fortify Vr U1 6 Sj4 Us | Product code NVZ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,564 | 95,612 | 26,136,888 |
| Share of that pool | — | 1.6% | 0% |
| Classified as death, per 1,000 reports | 12 | 41 | 9 |
| Classified as injury | 87.7% | 52.1% | 36.2% |
| Classified as malfunction | 11.1% | 43.5% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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 NVZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Adapta | 4,893 | 279 | 7.4% |
| Advisa MRI SureScan | 3,589 | 272 | 1.9% |
| Reply | 2,814 | 9 | 1.5% |
| Insignia | 3,792 | 0 | 1.3% |
| Altrua | 4,122 | 0 | 2.4% |
| Carelink | 15,005 | 18 | 0% |
| Sensia IPG | 1,391 | 73 | 2.7% |
| Dextrus 4136 | 5,698 | 0 | 0.8% |
| Azure | 919 | 0 | 1.8% |
| MyCareLink Patient Monitor | 893 | 47 | 0.1% |
| Pulse Generator Permanent Implantable | 852 | 24 | 1.1% |
| Ellipse VR | 1,507 | 45 | 3.7% |
| Symphony | 1,163 | 133 | 1.6% |
| Fortify Assura VR ICD, US | 4,888 | 213 | 2.3% |
| Consulta Crt-P | 680 | 5 | 4.7% |
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 Fortify Vr U1 6 Sj4 Us reports
How many FDA reports name Fortify Vr U1 6 Sj4 Us?
1,564 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.
What kinds of events are reported?
injury (87.7%), malfunction (11.1%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
battery problem (29.3%), premature discharge of battery (24.8%), failure to interrogate (8.8%), inappropriate/inadequate shock/stimulation (6.8%) and over-sensing (3.5%). 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 Fortify Vr U1 6 Sj4 Us 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.