FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 750090
·
Received August 9, 2006
Report
- Report Number
- 2124215-2006-15705
- Event Type
- Malfunction
- Date Received
- August 9, 2006
- Date of Event
- May 18, 2006
- Report Date
- May 18, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED JANUARY 16, 2004, PRESENTED WITH A BATTERY STATUS OF MIDDLE OF LIFE 2 (MOL 2) AT 2.62 V. THIS IMPLANATABLE TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS AT 3.0 V/1,OMS. THERE IS A CONCERN THAT THE BATTER HAS DEPLETED EARLIER THAN EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | LWS | CARDIAC PACEMAKERS, INC | H155 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |