FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1091503
·
Received August 1, 2008
Report
- Report Number
- 3004209178-2008-04559
- Event Type
- Injury
- Date Received
- August 1, 2008
- Report Date
- July 1, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SLID OFF OF A KITCHEN CHAIR AND ONTO THE FLOOR. ABOUT TEN DAYS LATER SHE EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND COULD NOT FEEL ANY STIMULATION. SHE HAD HER DEVICE REPLACED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 3095 LOT# NAH013900V| LEAD MODEL 3093 LOT# J0421510V |