FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1926038
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09227
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 22, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION. THEIR PT PROGRAMMER DISPLAY SHOWED A "CALL YOUR DOCTOR" ICON AND A POR (POWER ON RESET) CONDITION. PT JUST HAD HEART SURGERY AND WAS IN THE HOSP. WHEN FURTHER INFO IS AVAILABLE, IT WILL BE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD090385N| IMPLANTED:| LEAD: MODEL 3093, LOT# V314282| EXTENSION: MODEL 3095, LOT# NAH043857V |