Devices › Implantable cardioverter defibrillator (non-crt)
Device brand name · Implantable cardioverter defibrillator non-crt
Aurora EV-ICD MRI SureScan: medical device reports filed with FDA
633 reports name it, 2023–2026. Manufacturer given most often on reports: Medtronic Europe Sarl. Product code LWS.
- 633
- device reports naming the brand
- 0% of all MAUDE reports · about 238 a year
- 337
- reports, 12 months to August 2026
- 224 in the 12 months before
- 20.4%
- classified as malfunction
- 37.4% across the product code
- 2.2%
- classified as death, as reported
- 14 reports · not verified by FDA
633 medical device reports received by FDA name the brand "Aurora EV-ICD MRI SureScan" (implantable cardioverter defibrillator non-crt); the manufacturer given most often on reports is Medtronic Europe Sarl; received from November 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
337 reports arrived in the 12 months to August 2026, up 50% from 224 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 (77.4%), malfunction (20.4%) and death (2.2%); 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 (27.8%), inappropriate/inadequate shock/stimulation (24%) and electromagnetic interference (14.8%). The patient problems coded most often are shock from patient lead(s), erythema and pain. 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 | 176 | 27.8% | 3.9% |
| Inappropriate/inadequate shock/stimulation | 152 | 24% | 12.8% |
| Electromagnetic interference | 94 | 14.8% | 0.6% |
| Signal artifact/noise | 58 | 9.2% | 8% |
| Over-sensing | 54 | 8.5% | 21.1% |
| Pacing problem | 41 | 6.5% | 3.8% |
| Failure to convert rhythm | 33 | 5.2% | 0.9% |
| Defibrillation/stimulation problem | 24 | 3.8% | 1% |
| Under-sensing | 16 | 2.5% | 3.1% |
| Electrical /electronic property probleman electrical or electronic problem | 13 | 2.1% | 0.8% |
| Migration or expulsion of device | 13 | 2.1% | 0.3% |
| Failure to deliver shock/stimulation | 12 | 1.9% | 0.3% |
| Failure to interrogate | 8 | 1.3% | 0.9% |
| Mechanical problema mechanical problem | 7 | 1.1% | 1% |
| Unable to obtain readings | 7 | 1.1% | 0.1% |
| High impedance | 6 | 0.9% | 15.6% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 0.5% | 0.4% |
| Insufficient device problem information | 3 | 0.5% | 1.7% |
| Battery problema problem with the battery | 2 | 0.3% | 2% |
| Device alarm system | 2 | 0.3% | 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 |
|---|---|---|
| Shock from patient lead(s) | 153 | 24.2% |
| Erythemaskin redness | 43 | 6.8% |
| Painpain, site not specified | 39 | 6.2% |
| Discomfortdiscomfort | 34 | 5.4% |
| Purulent discharge | 33 | 5.2% |
| Wound dehiscencea wound reopened | 29 | 4.6% |
| Medical device site infectioninfection at the device site | 24 | 3.8% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 24 | 3.8% |
| Tachycardiafast heart rate | 20 | 3.2% |
| Bacterial infectiona bacterial infection | 18 | 2.8% |
| Chest painchest pain | 18 | 2.8% |
| Erosion | 16 | 2.5% |
| Swelling/ edema | 16 | 2.5% |
| Atrial fibrillationan irregular heart rhythm | 11 | 1.7% |
| Fluid discharge | 11 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Aurora EV-ICD MRI SureScan | Product code LWS | All MAUDE reports |
|---|---|---|---|
| Reports | 633 | 380,959 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 22 | 27 | 9 |
| Classified as injury | 77.4% | 59.6% | 36.2% |
| Classified as malfunction | 20.4% | 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 Aurora EV-ICD MRI SureScan reports
How many FDA reports name Aurora EV-ICD MRI SureScan?
633 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 337 in the latest 12 months.
What kinds of events are reported?
injury (77.4%), malfunction (20.4%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (27.8%), inappropriate/inadequate shock/stimulation (24%), electromagnetic interference (14.8%), signal artifact/noise (9.2%) and over-sensing (8.5%). 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 Aurora EV-ICD 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.