Devices › Implantable cardioverter defibrillator (non-crt)
Device brand name · Implantable cardioverter defibrillator non-crt
Cobalt XT VR MRI SureScan: medical device reports filed with FDA
821 reports name it, 2021–2026. Manufacturer given most often on reports: Medtronic Europe Sarl. Product code LWS.
- 821
- device reports naming the brand
- 0% of all MAUDE reports · about 149 a year
- 272
- reports, 12 months to August 2026
- 189 in the 12 months before
- 23.1%
- classified as malfunction
- 37.4% across the product code
- 1.3%
- classified as death, as reported
- 11 reports · not verified by FDA
821 medical device reports received by FDA name the brand "Cobalt XT VR MRI SureScan" (implantable cardioverter defibrillator non-crt); the manufacturer given most often on reports is Medtronic Europe Sarl; received from January 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
272 reports arrived in the 12 months to August 2026, up 44% from 189 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 (75.5%), malfunction (23.1%) and death (1.3%); 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 device sensing problem (35.4%), inappropriate/inadequate shock/stimulation (24.2%) and pacing problem (17.9%). The patient problems coded most often are shock from patient lead(s), erythema and purulent discharge. 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 |
|---|---|---|---|
| Device sensing problem | 291 | 35.4% | 3.9% |
| Inappropriate/inadequate shock/stimulation | 199 | 24.2% | 12.8% |
| Pacing problem | 147 | 17.9% | 3.8% |
| Defibrillation/stimulation problem | 44 | 5.4% | 1% |
| Mechanical problema mechanical problem | 35 | 4.3% | 1% |
| Electromagnetic interference | 31 | 3.8% | 0.6% |
| Failure to deliver shock/stimulation | 25 | 3% | 0.3% |
| Inappropriate or unexpected reset | 23 | 2.8% | 1.1% |
| Over-sensing | 23 | 2.8% | 21.1% |
| High impedance | 15 | 1.8% | 15.6% |
| Reset problem | 15 | 1.8% | 0.3% |
| Signal artifact/noise | 15 | 1.8% | 8% |
| Migration or expulsion of device | 13 | 1.6% | 0.3% |
| Impedance problem | 9 | 1.1% | 4.4% |
| Misconnection | 9 | 1.1% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 7 | 0.9% | 0.4% |
| Output problem | 5 | 0.6% | 0.2% |
| Low impedance | 4 | 0.5% | 2.8% |
| Battery problema problem with the battery | 3 | 0.4% | 2% |
| Failure to interrogate | 3 | 0.4% | 0.9% |
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) | 201 | 24.5% |
| Erythemaskin redness | 39 | 4.8% |
| Purulent discharge | 32 | 3.9% |
| Bacteremia | 29 | 3.5% |
| Swelling/ edema | 29 | 3.5% |
| Tachycardiafast heart rate | 28 | 3.4% |
| Discomfortdiscomfort | 26 | 3.2% |
| Medical device site infectioninfection at the device site | 26 | 3.2% |
| Wound dehiscencea wound reopened | 24 | 2.9% |
| Fever | 21 | 2.6% |
| Syncope/fainting | 20 | 2.4% |
| Erosion | 19 | 2.3% |
| Bacterial infectiona bacterial infection | 17 | 2.1% |
| Painpain, site not specified | 17 | 2.1% |
| Bradycardiaslow heart rate | 15 | 1.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cobalt XT VR MRI SureScan | Product code LWS | All MAUDE reports |
|---|---|---|---|
| Reports | 821 | 380,959 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 13 | 27 | 9 |
| Classified as injury | 75.5% | 59.6% | 36.2% |
| Classified as malfunction | 23.1% | 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 Cobalt XT VR MRI SureScan reports
How many FDA reports name Cobalt XT VR MRI SureScan?
821 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 272 in the latest 12 months.
What kinds of events are reported?
injury (75.5%), malfunction (23.1%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (35.4%), inappropriate/inadequate shock/stimulation (24.2%), pacing problem (17.9%), defibrillation/stimulation problem (5.4%) and mechanical problem (4.3%). 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 Cobalt XT VR MRI SureScan 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.