FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2061834
·
Received April 4, 2011
Report
- Report Number
- 3004209178-2011-02556
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST THEIR STIMULATION AND SAW A "CALL YOUR DOCTOR" ICON MESSAGE WAS SEEN ON THE PT PROGRAMMER. A POWER-ON-RESET (POR) CONDITION ON THE PT'S DEVICE WAS ALSO REPORTED. THE PT DID NOT HAVE ANY RECENT MEDICAL PROCEDURES. ADD'L INFO WAS REQUESTED.
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 | 58 YR | PROGRAMMER: MODEL 3037, LOT# NJD041614N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V018108 |