FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2010550
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01502
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 17, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A GRADUAL LOSS OF THERAPEUTIC EFFECT. THE PT NOTED THAT IT HAD BEEN ABOUT ONE YR SINCE HER DEVICE WAS CHECKED AND THAT PREVIOUSLY SHE HAD IT CHECKED EVERY 3 MONTHS. SHE MET WITH HER PHYSICIAN AND WITH THE COMPANY REP FOR EVENT. SHE HAD SURGERY TO FIX THE DEVICE PROBLEM. 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 | 80 YR | Required Intervention | LEAD: MODEL 3889, LOT# V017498| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH030188V| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031A, NGM029063P| IMPLANTED: |