FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1080199
·
Received July 22, 2008
Report
- Report Number
- 3004209178-2008-04236
- Event Type
- Injury
- Date Received
- July 22, 2008
- Report Date
- June 23, 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
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE PT REPORTED THAT HER DEVICE WAS NOT IMPLANTED DEEP ENOUGH AND IT "BUNCHED UP UNDER HER SKIN". THE DEVICE WAS MOVED TO THE OPPOSITE SIDE OF HER BODY AND SINCE THEN HAS NOT BEEN SUCCESSFUL. THE PT ALSO EXPERIENCED INADVERTENT INCREASES IN HER STIMULATION FOR AT LEAST SIX MONTHS. 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:| EXTENSION MODEL 3095 LOT# NAH028483V| LEAD MODEL 3093 LOT# V003011| EXPLANTED:| IMPLANTED: |