FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL TR
MDR report key: 2050585
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03480
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NKE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO POCKET EROSION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED ON THE PATIENT'S RIGHT SIDE.
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 | 91 YR | Required Intervention | MISMATCH| H120| 4194| 8042 |