FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 4963002
·
Received July 31, 2015
Report
- Report Number
- 3009448963-2015-00471
- Event Type
- Injury
- Date Received
- July 31, 2015
- Date of Event
- July 14, 2015
- Report Date
- July 14, 2015
- Manufacturer
- CAMERON HEALTH INC.
- Product Code
- NVY
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE PROTRUDED AT THE POCKET SCAR LOCATION AND WAS PARTIALLY EXPOSED. THE PHYSICIAN REPORTED NO INFECTION; HOWEVER, STATED INTERVENTION WOULD BE SCHEDULED TO CORRECT THE EROSION AND RECLOSE THE POCKET. NO OTHER ADVERSE EFFECTS WERE REPORTED AND THE PATIENT HOSPITALIZED FOR A REVISION. THE DEVICE AND ASSOCIATED ELECTRODE WERE LATER EXPLANTED, WITH NO FURTHER ADVERSE EFFECTS REPORTED AND NO INFORMATION PROVIDED ON A REPLACEMENT SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499100 | S-ICD SYSTEM | IMPLANTABLE LEAD | NVY | CAMERON HEALTH INC. | 3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 1010 |