FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 3193522
·
Received June 25, 2013
Report
- Report Number
- 3009448963-2013-00076
- Event Type
- Injury
- Date Received
- June 25, 2013
- Date of Event
- April 18, 2013
- Report Date
- June 6, 2013
- Manufacturer
- CAMERON HEALTH
- Product Code
- LWS
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFO IS CURRENTLY AVAILABLE. ONCE ANY ADDITIONAL INFO DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFO THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPLANTED DUE TO AN INFECTION IN THE POCKET. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287998 | S-ICD SYSTEM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CAMERON HEALTH | 1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |