FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1170708
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05790
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- July 1, 2008
- Report Date
- August 18, 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 Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A JOLTING SENSATION IN HIS BUTTOCKS. IT STARTED APPROXIMATELY ONE MONTH AGO WHEN HE WAS SITTING IN A CHAIR WITH HIS LEGS UP. HE WAS CONCERNED THAT HE PUT TOO MUCH PRESSURE ON THE LEADS AND THAT THEY WERE PULLED OUT OF PLACE. HE WAS AT HOME IN FAIR CONDITION. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | LEAD: MODEL 3093| EXPLANTED| PROGRAMMER: MODEL 3037 |