FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1913536
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09405
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 5, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A POWER-ON-RESET (POR) CONDITION WAS REPORTED AND A "CALL DOCTOR: POR" ICON MESSAGE WAS SEEN ON THE PT PROGRAMMER AFTER HER DEVICE WAS REPLACED YESTERDAY. IT WAS NOTED THAT THE COMPANY REPRESENTATIVE HAD PROGRAMMED HER DEVICE AND "SYNCHED IT" TO THE PT PROGRAMMER. ADDITIONAL 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 | 83 YR | LEAD: MODEL 3093, LOT # V164575| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD078732N| EXPLANTED: |