FDA Adverse Event
Malfunction
Summary report: N
VENTAK MINI IV+
MDR report key: 674832
·
Received February 9, 2006
Report
- Report Number
- 2124215-2006-11576
- Event Type
- Malfunction
- Date Received
- February 9, 2006
- Date of Event
- September 9, 2005
- Report Date
- November 11, 2005
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT REPORTES THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS BEEPING AT ODD INTERVALS. A CHECK OF THE DEVICE FOUND IT TO BE AT AN ERI (ELECTIVE REPLACEMENT INDICATOR) BATTERY STATUS. THE BEEP ON ERI FEATURE WAS PROGRAMMED TO OFF. HOWEVER, AFTERWARD, THE PATIENT STILL REPORTED HEARING ODD TONES COMING FROM THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK MINI IV+ | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1793 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |