FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1960938
·
Received January 11, 2011
Report
- Report Number
- 3004209178-2011-00262
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- April 28, 2010
- Report Date
- October 5, 2016
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEUROSTIMULATOR ON THE RIGHT SIDE OF THE PT (PT HAD 2 DEVICE SYSTEMS) ERODED THROUGH THE SKIN AND WAS EXPLANTED. SHE WAS AT HOME IN GOOD CONDITION. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention | EXPLANTED:| EXTENSION: MODEL 3095, LOT#: NAH046080V| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT#: NJD103401N| PROGRAMMER: MODEL 3037, LOT#: NJD103401N| EXPLANTED:| EXTENSION: MODEL 3095, LOT#: NAH046080V| IMPLANTED: |