FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 4240401
·
Received October 30, 2014
Report
- Report Number
- 3009448963-2014-00298
- Event Type
- Injury
- Date Received
- October 30, 2014
- Date of Event
- October 16, 2014
- Report Date
- October 16, 2014
- Manufacturer
- CAMERON HEALTH
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- 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 PRODUCT WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS KEPT BY THE HOSPITAL PATHOLOGY DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695235 | S-ICD SYSTEM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CAMERON HEALTH | 1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | 3010 |