FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2010558
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01509
- Event Type
- Injury
- Date Received
- March 1, 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
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS HAVING ISSUES BACK IN 2007 WITH PASSING OUT AND THE CAUSE COULD NOT BE DETERMINED. THE PT HAD THE DEVICE EXPLANTED. WHEN SHE HAD BOTH A MRI AND X-RAY DONE 2 MONTHS AGO, IT WAS FOUND THAT THE LEAD WAS STILL IN PLACE. IT WAS NOTED THAT THE PT HAD MULTIPLE SCLEROSIS AND MAY NEED TO HAVE THE LEAD EXPLANTED DUE TO A NEED FOR A MEDICAL PROCEDURE (NOT SPECIFIED). ADDITIONAL 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 | Required Intervention | IMPLANTED:| LEAD: MODEL 3093, LOT# J0327000V| IMPLANTED:| LEAD: MODEL 3093, LOT# J0327000V| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM008004P| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH010083V| EXPLANTED:| IMPLANTED: |