FDA Adverse Event
Malfunction
Summary report: N
GEM II DR
MDR report key: 268215
·
Received March 13, 2000
Report
- Report Number
- 2647346-2000-00069
- Event Type
- Malfunction
- Date Received
- March 13, 2000
- Date of Event
- January 6, 2000
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
NO SENSING OR PACING ON V SIDE AT IMPLANT. DEVICE TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEM II DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7273 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |