FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2227741
·
Received August 15, 2011
Report
- Report Number
- 3004209178-2011-06333
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Report Date
- July 20, 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
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT COULD NOT FEEL STIMULATION FOLLOWING A SURGICAL PROCEDURE TO REMOVE ADHESIONS. COMMUNICATION/COUPLING ISSUES WERE ALSO REPORTED. A "POOR COMMUNICATION" SCREEN WAS DISPLAYED ON THE PT PROGRAMMER AND THE HEALTHCARE PROVIDER WAS UNABLE TO ADJUST STIMULATION. THERE WAS DIFFICULTY SYNCING THE CLINICIAN PROGRAMMER AND THE PT PROGRAMMER. ADDITIONAL 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD064509N| LEAD: MODEL 3093, LOT# V076001| EXPLANTED: |