FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 1072858
·
Received July 10, 2008
Report
- Report Number
- 6000094-2008-00322
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- May 8, 2008
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | ADDRS1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |