FDA Adverse Event
Injury
Summary report: N
S-ICD SYSTEM
MDR report key: 5090838
·
Received September 21, 2015
Report
- Report Number
- 3009448963-2015-00541
- Event Type
- Injury
- Date Received
- September 21, 2015
- Date of Event
- August 25, 2015
- Report Date
- August 26, 2015
- Manufacturer
- CAMERON HEALTH
- Product Code
- LWS
- UDI-DI
- 00802526562808
- PMA / PMN Number
- P11042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
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 THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE DEVELOPED AN INFECTION AT THE INCISION SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ANTIBIOTICS WERE ADMINISTERED WHICH CLEARED THE INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622182 | S-ICD SYSTEM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CAMERON HEALTH | 1010 | 00802526562808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| L| R | 3010 |