FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC INC.
MDR report key: 633894
·
Received September 1, 2005
Report
- Report Number
- 633894
- Event Type
- Malfunction
- Date Received
- September 1, 2005
- Date of Event
- July 15, 2005
- Manufacturer
- *
- Product Code
- ---
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MALFUNCTIONING PACEMAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC INC. | PACEMAKER-ICD/IPG, LEADS & ADAPTERS | --- | * | 7274 | NA | |
| 2 | MEDTRONIC INC. | PACEMAKER-ICD/IPG, LEADS & ADAPTERS | --- | * | 6947-65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |