FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 1951634
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-24403
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- November 19, 2010
- Report Date
- November 26, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEAD REMAIN IN SERVICE. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED OUT-OF-RANGE PACING IMPEDANCE ON A DEFIBRILLATION LEAD. IT WAS ALSO DISCUSSED THAT THIS DEVICE WAS TO BE PROGRAMMED OFF AND A LEAD REVISION TO LATER TAKE PLACE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | 4472| 1280| H170| 6949| 4470| 4517 |