FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1872394
·
Received October 11, 2010
Report
- Report Number
- 3007566237-2010-07814
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 16, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN STIMULATION IS TURNED ON, THE PT EXPERIENCES A SHOCKING OR JOLTING SENSATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC NEUROMODULATION | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNKNOWN |