FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 4152534
·
Received August 11, 2014
Report
- Report Number
- 3009448963-2014-00176
- Event Type
- Injury
- Date Received
- August 11, 2014
- Date of Event
- July 15, 2014
- Report Date
- July 15, 2014
- Manufacturer
- CAMERON HEALTH
- Product Code
- NVY
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PT WEIGHT: NOT AVAILABLE. 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 THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS EXPLANTED AS THE PHYSICIAN SUSPECTED THERE WAS AN INFECTION OF THE DEVICE POCKET. CULTURES WERE DONE, HOWEVER, THE FIELD REP WAS UNAWARE OF THE RESULTS. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476047 | S-ICD SYSTEM | IMPLANTABLE LEAD | NVY | CAMERON HEALTH | 3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| L| R | 1010 |