IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Report
- Report Number
- 2124215-2025-73487
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- September 22, 2025
- Report Date
- October 29, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL CORRECTION REPORT WAS CREATED TO CAPTURE THE ADDITIONAL INFORMATION RECEIVED WHICH INDICATES THAT THE PATIENT AND PRODUCT INFORMATION INITIALLY REPORTED BY THE FACILITY WAS INCORRECT. NO INFECTIONS, MALFUNCTIONS OR ADVERSE EFFECTS WERE OBSERVED WITH THE PATIENT WITH L331/913477. L331/913477 IS CURRENTLY IN SERVICE. AMENDING MDR DECISION TO MDR=NO REPORT.
IT WAS REPORTED THAT THE PATIENT WITH THIS LEAD HAD AN INFECTION DUE TO A PINHOLE-LIKE PROTRUSION THROUGH THE SKIN WITH REDNESS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT AND PRODUCT INFORMATION INITIALLY REPORTED BY THE FACILITY WAS INCORRECT. NO INFECTIONS, MALFUNCTIONS OR ADVERSE EFFECTS WERE OBSERVED WITH THE PATIENT.
IT WAS REPORTED THAT THE PATIENT WITH THIS LEAD HAD AN INFECTION DUE TO A PINHOLE-LIKE PROTRUSION THROUGH THE SKIN WITH REDNESS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE LEAD REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2773114 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Female | Hospitalization| R |