FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1990776
·
Received February 8, 2011
Report
- Report Number
- 3004209178-2011-00957
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- April 22, 2010
- Report Date
- January 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS, (B)(4) ((B)(4) 2010).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE EXPLANTATION PROCEDURE, THE DISTAL TIP OF THE LEAD BROKE OFF AND REMAINED IN THE PT. THE REASON FOR THE NEUROSTIMULATOR SYSTEM REMOVAL WAS THE PT NEED FOR AN MRI. THE PT WAS REPORTED AS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V092230| PROGRAMMER: MODEL 3037, LOT# NJD069067N |