FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL TR
MDR report key: 2153649
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-07021
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 8, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NKE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYNCOPAL EPISODE. THE HEALTH CARE PERSONNEL ALSO WANTED TO KNOW HOW TO TURN THE MAGNET STORAGE FEATURE ON.
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 | 33 YR | Required Intervention | 4469| 4592| H120| 4470 |