FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1231235
·
Received November 13, 2008
Report
- Report Number
- 3004209178-2008-07431
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- 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 THAT DURING IMPLANT, IMPEDANCES WERE GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS. STIMULATION WAS POSSIBLE USING CASE AND THE "0" ELECTRODE. IT WAS NECESSARY TO REPROGRAM AROUND ELECTRODES THAT WERE READING HIGH IMPEDANCE TO GET SATISFACTORY RESULTS. NO INJURY TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | IPG URO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| LEAD: MODEL LEAD, LOT # UNKNOWN| IMPLANTED: |