FDA Adverse Event
Malfunction
Summary report: N
EMBLEM MRI S-ICD
MDR report key: 22561264
·
Received July 21, 2025
Report
- Report Number
- 2124215-2025-48913
- Event Type
- Malfunction
- Date Received
- July 21, 2025
- Date of Event
- July 13, 2025
- Report Date
- July 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526581519
- PMA / PMN Number
- P110042/S058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DELIVERED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF A COMBINATION OF T-WAVES AND NOISE. AT THE TIME OF THE SHOCK, THE PATIENT WAS BICYCLING ON A VERY UNEVEN SURFACE. THE CLINIC HAS ASSESSED THIS TO BE AN ISOLATED INCIDENT, AND THE PATIENT WAS DISCHARGED HOME AND WILL CONTINUE WITH NORMAL FOLLOW-UPS. BESIDES THE INAPPROPRIATE THERAPY, NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802997 | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | A219 | 252359 | 00802526581519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Unknown |