FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1841855
·
Received September 21, 2010
Report
- Report Number
- 3004209178-2010-07138
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- July 1, 2010
- Report Date
- August 22, 2010
- 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
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED NO STIMULATION SENSATION FOLLOWING A FALL ON THE DEVICE, "ABOUT A MONTH AGO". THE PT'S URINARY SYMPTOMS (UNSPECIFIED) AROSE TWO TO THREE WEEKS AGO. THE PT WAS NOT ABLE TO MAKE ADJUSTMENTS TO STIMULATION BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. IT WAS NOTED THAT THE RETURNED PT PROGRAMMER HAD A CRACKED SOLDER JOINT. PIN 2 OF THE ANTENNA JACK WAS RESOLDERED. THE PT RECEIVED A REPLACEMENT PT PROGRAMMER, BUT STILL RECEIVED COMMUNICATION ERRORS. THE PT WAS STILL NOT ABLE TO ADJUST STIMULATION. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
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 | 61 YR | PROGRAMMER: MODEL 3037, LOT#: NJD064919N| IMPLANTED:| LEAD: MODEL 3889, LOT#: V063307| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT#: V082511| IMPLANTED:| EXPLANTED: |