FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 1851831
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-14203
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- July 11, 2010
- Report Date
- July 11, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOCAL AREA SALES REPRESENTATIVE ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
THE LOCAL AREA SALES REPRESENTATIVE ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A LATITUDE ALERT WAS ISSUED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO THE DEVICE BEING IN MONITOR ONLY. 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 | H215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | 4518| 4470| 0185| H215 |