FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL TR
MDR report key: 1950457
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22377
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NKE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 FROM THE PATIENT THAT THIS PRODUCT WAS PART OF A SYSTEM INFECTION. THE PATIENT HAS AN APPOINTMENT WITH HIS PHYSICIAN IN THE NEAR FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL TR | IMPLANTABLE CHF GENERATOR | NKE | GUIDANT CRM CLONMEL IRELAND | H120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Life Threatening | H120| 4471| 4543 |