FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3162431
·
Received June 11, 2013
Report
- Report Number
- 3007566237-2013-01925
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- January 1, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS NOTED THAT THE REPORTER HAD SEEN AN ISSUE WITH A TRIAL LEAD ABOUT 3 YEARS AGO. IT WAS BELIEVED THAT THE DOCTOR PROBABLY TRAPPED THE END OF THE LEAD WHERE THE STYLET IS WITH THE NEEDLE HUB AND IT STRETCHED OUT. THE DOCTOR STARTED OVER WITH NEW TEMPORARY LEAD. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262112 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | 3057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |