FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1162257
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05817
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 19, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION AT THE POCKET REGARDLESS OF WHETHER THE STIMULATION WAS OFF OR ON. THE PATIENT LOST EIGHTY POUNDS AND THE IPG SUBSEQUENTLY BECAME LOOSE IN THE POCKET. IMPEDANCE MEASUREMENTS WERE NORMAL. 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 | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | PROGRAMMER: MODEL 3031A| CATHETER: MODEL 8709| EXTENSION: MODEL 3095| EXPLANTED:| LEAD: MODEL 3889| EXPLANTED:| IMPLANTED:| PUMP: MODEL 8627L18 |