FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1191130
·
Received September 26, 2008
Report
- Report Number
- 3004209178-2008-06147
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Report Date
- August 28, 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
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION TWICE IN HER LEGS AND AT THE DEVICE SITE. THE FIRST TIME IT HAPPENED, THE PATIENT WAS CLOSE TO A LARGE T.V. THE SECOND TIME SHE WAS SITTING ON A COUCH NOT CLOSE TO A T.V. THE SHOCKING SENSATION WAS VERY PAINFUL. IT CAUSED HER TO SCREAM AND TO NOT BE ABLE TO MOVE. SHE WAS RECEIVING SYMPTOM RELIEF. FURTHER INFORMATION 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. | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROGRAMMER: MODEL 3037| LEAD: MODEL 3093| IMPLANTED:| EXPLANTED: |