FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1081284
·
Received July 24, 2008
Report
- Report Number
- 3004209178-2008-04325
- Event Type
- Injury
- Date Received
- July 24, 2008
- Report Date
- June 26, 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT. WHEN THE MDT REP INCREASED THE VOLTAGE, THE PT FELT THE SHOCKING. THE HCP CONFIRMED THAT THE PT HAS BILATERAL STIMULATORS AND THE RIGHT SIDE WAS NO LONGER FUNCTIONING. THE PT EXPERIENCED A LACK OF EFFECT, NO STIMULATION AND URINARY ISSUES. THE PT'S RIGHT LEAD WAS REPLACED AND FUNCTION WAS RESTORED. THE PT RECOVERED WITHOUT SEQUELA.
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 | Required Intervention | LEAD MODEL 3889 LOT# V042810| LEAD MODEL 3889 LOT# V020897| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED |