FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2190798
·
Received July 28, 2011
Report
- Report Number
- 3004209178-2011-05858
- Event Type
- Injury
- Date Received
- July 28, 2011
- Report Date
- July 1, 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
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER ONE YEAR OF USE, THE THERAPY WAS NO LONGER WORKING. THE NEUROSTIMULATOR WAS NOT ABLE TO BE INTERROGATED, AND THE DEVICE WAS DETERMINED TO BE "EMPTY." THE NEUROSTIMULATOR WAS EXPLANTED AND REPLACED, AND THERAPY WAS WORKING AGAIN. THE PATIENT'S STATUS WAS REPORTED AS "OK." ADDITIONAL INFORMATION 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 | Required Intervention |