FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 3181513
·
Received June 17, 2013
Report
- Report Number
- 3009448963-2013-00068
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 30, 2013
- Manufacturer
- CAMERON HEALTH
- Product Code
- LWS
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 THIS PT DEVELOPED AN INFECTION AND THE ENTIRE SYSTEM WAS EXPLANTED. THE INFECTION ORIGINATED FROM AROUND THE SUPERIOR INCISION OF THE S-ICD POCKET. THE PT HAD PRESENTED TWO DAYS PRIOR AND UPON INSPECTION, THE INFECTION WAS FOUND THROUGHOUT THE POCKET AND ENTIRE SYSTEM. THE PT WILL START ANTIBIOTICS. THE S-ICD WILL BE RETURNED, HOWEVER, THE LEAD WAS MAINTAINED BY THE HOSPITAL FOR CULTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273662 | S-ICD SYSTEM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR-PROD CODE LWS | LWS | CAMERON HEALTH | 1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Hospitalization| L| R |