FDA Adverse Event
Malfunction
Summary report: N
MEDTRONICS INC.
MDR report key: 233442
·
Received July 27, 1999
Report
- Report Number
- 233442
- Event Type
- Malfunction
- Date Received
- July 27, 1999
- Date of Event
- October 30, 1998
- Report Date
- November 9, 1998
- Manufacturer
- MEDTRONIC INC.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LEAD MALFUNCTION AND GENERATION UPDATED. LEAD LEFT IN PLACE, UNABLE TO REMOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONICS INC. Implant | IMPLANTABLE CARDIAC DEFIBRILLATOR GENERATOR | DXY | MEDTRONIC INC. | 7223CX (GENERATOR) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |