FDA Adverse Event
Death
Summary report: N
DISCOVERY DR
MDR report key: 262913
·
Received February 9, 2000
Report
- Report Number
- 2124215-2000-01448
- Event Type
- Death
- Date Received
- February 9, 2000
- Date of Event
- December 10, 1999
- Report Date
- December 10, 1999
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION A PHYSICIAN CALLED TECHNICAL SERVICES TO REPORT THAT THE PATIENT WITH THIS IMPLANTABLE PULSE GENERATOR (IPG) HAD EXPIRED FROM VENTRICULAR TACHYCARDIA. THE PATIENT HAD BEEN IN A PROLONGED SURGERY, WHICH LED TO MULTIPLE PVC'S (PREMATURE VENTRICULAR CONTRACTIONS) POST SURGERY. DUE TO THESE PVC'S THE DEVICE UNDERSENSED AND PACED AND THE PATIENT'S T-WAVE, THUS INDUCING THE VENTRICULAR TACHYCARDIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISCOVERY DR | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 1274 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death |