FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 3193523
·
Received June 25, 2013
Report
- Report Number
- 3009448963-2013-00075
- Event Type
- Injury
- Date Received
- June 25, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 11, 2013
- Manufacturer
- CAMERON HEALTH
- Product Code
- NVY
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCTS ARE NOT EXPECTED TO BE RETURNED. 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 THE PT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXPERIENCED AN INFECTION APPROXIMATELY TWO WEEKS AFTER THE DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED. THE DEVICE AND ELECTRODE WERE EXPLANTED AND THE PT IS BEING TREATED FOR THE INFECTION CURRENTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288798 | S-ICD SYSTEM | IMPLANTABLE LEAD | NVY | CAMERON HEALTH | 3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |