FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 4152481
·
Received July 14, 2014
Report
- Report Number
- 3009448963-2014-00144
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 24, 2014
- Manufacturer
- CAMERON HEALTH
- Product Code
- LWS
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFO THAT THERE WAS ULCERATION AND NECROSIS OF THE TISSUE FOUND AT THE POCKET SITE. THE REASON FOR THE ULCERATION NECROSIS WAS NOT KNOWN. A REVISION PROCEDURE WAS PERFORMED AND THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPLANTED. THE ELECTRODE REMAINS IMPLANTED. THE PT WAS DISCHARGED TO HOME WITH A LIFE VEST AND WILL UNDERGO ND A DEVICE REPLACEMENT IN THE FUTURE. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410119 | S-ICD SYSTEM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CAMERON HEALTH | 1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | 3010 |