FDA Adverse Event
Injury
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 68871
·
Received January 9, 1997
Report
- Report Number
- 2124215-1997-00030
- Event Type
- Injury
- Date Received
- January 9, 1997
- Date of Event
- June 3, 1996
- Report Date
- August 1, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PACEMAKER DEPENDENT PATIENT WITH THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXHIBITING EARLY BATTERY DEPLETION. THE MAGNET RATE IS AT 87. CPI HAS BEEN UNABLE TO OBTAIN A SERIAL NUMBER OR PATIENT NAME AND THEREFORE DOES NOT KNOW THE IMPLANT DATE OF THIS IPG. INFORMATION RECEIVED INDICATED THAT THE 'PACER MAY BE EXPLANTED', THEREFORE THIS IS BEING FILED AS A SERIOUS INJURY MDR. CPI MINIMUM LONGEVITY AT NOMINAL SETTINGS WITH A 500 OHM LEAD IS 42 MONTHS. CPI DOES NOT KNOW THE IMPLANT PARAMETERS OR THE LEAD RESISTANCE THROUGHOUT THE IMPLANT LIFE OF THE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTA DDD PULSE GENERATOR | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0940 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |