INTERSTIM II
Report
- Report Number
- 3004209178-2012-12051
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Report Date
- November 29, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V466208, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT ABOUT TWO MONTHS AGO THE PATIENT STOPPED GETTING "GOOD" THERAPY. IT WAS REPORTED THAT THERE APPEARED TO BE A PROBLEM WITH IMPEDANCES. IT WAS NOTED THAT SOME OF THE VALUES FOR BIPOLAR PAIRS WERE THE SAME AS THE UNIPOLAR PAIRS. THE REPORTER STATED THAT ELECTRODE #1 SEEMED TO HAVE A PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPROGRAMMING OCCURRED ON (B)(6) 2012. THE MANUFACTURE REPRESENTATIVE PERFORMED THE REPROGRAMMING AND THE PATIENT HAD NOT FOLLOWED ¿BACK UP¿ SO RESCHEDULED THE APPOINTMENT. THE PATIENT HAD INCREASED FREQUENCY AND DECREASED EFFECTIVENESS. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |