FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1841895
·
Received September 20, 2010
Report
- Report Number
- 3004209178-2010-07119
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 20, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED HIGH IMPEDANCE READING AND A LOSS OF THERAPEUTIC EFFECT DURING STIMULATION. COMPANY REPRESENTATIVE NOTED READING >4000 OHMS ON ALL OF THE BIPOLAR PAIRS. IT WAS RECOMMENDED TO INCREASE DEFAULT TEST VALUES AND RE-RUN TEST. THE PATIENT WAS NOT PRESENT AT THE TIME SO, THEY WERE UNABLE TO RETEST IMPEDANCES. PATIENT WAS PROGRAMMED TO 3+2-. IT WAS LATER REPORTED IMPEDANCES WERE TESTED AND INDICATED HIGH IMPEDANCES. PATIENT HAD PARTIAL LOSS OF BENEFIT. IT WAS NOTED THEY HAD PROGRAMMED THE IMPLANTABLE NEURO STIM SO THAT THE ELECTRODES WITH GOOD IMPEDANCES WERE TURNED ON. THE PATIENT WAS DOING FINE. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN 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 | 48 YR | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V066807| PROGRAMMER: MODEL 3037, LOT# NJD058604N| IMPLANTED:| IMPLANTED: |