FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2181471
·
Received July 5, 2011
Report
- Report Number
- 3004209178-2011-05088
- Event Type
- Malfunction
- Date Received
- July 5, 2011
- Date of Event
- June 1, 2011
- Report Date
- November 21, 2011
- Manufacturer
- MEDTRONIC 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
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, A SHOCKING OR JOLTING SENSATION OCCURRED. IT WAS REPORTED THAT FOLLOWING A THEFT DETECTOR OR SECURITY GATE EXPOSURE, THE SHOCKING OR JOLTING OCCURRED. THE PT'S STATUS WAS REPORTED AS GOOD. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT #V516453.| PROGRAMMER: MODEL 3037, LOT #NJD113140N.| LEAD: MODEL 3889, LOT #V516453| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT #NJD113140N| EXPLANTED: |