FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1930041
·
Received November 18, 2010
Report
- Report Number
- 3004209178-2010-09772
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 11, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH IMPEDANCE READINGS >4000 OHMS WERE NOTED ON SOME OF THE BIPOLAR PAIRS WITH ALL COMBINATIONS OF ELECTRODE 0 NOTED AS OUT OF RANGE. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT #: NJD097057N| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT #: UNKNOWN| EXTENSION: MODEL 3095, LOT #: NAH041029V| LEAD: MODEL 3889, LOT #: V339125| IMPLANTED: |