INTERSTIM II
Report
- Report Number
- 3004209178-2017-09082
- Event Type
- Malfunction
- Date Received
- April 26, 2017
- Date of Event
- March 31, 2017
- Report Date
- August 15, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- UDI-DI
- 00613994913654
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER (CON). IT WAS REPORTED THAT THE PLUS BUTTON WOULDN'T ALLOW THE PATIENT TO GO UP.
A CONSUMER REPORTED THEY SAW THE NURSE PRACTITIONER (NP) ON (B)(6) 2017, BUT THEY WERE UNABLE TO INCREASE STIMULATION AND SAW THE ¿UPPER LIMIT¿ REACHED ON THE PATIENT PROGRAMMER (PP). THE PP TRIED TO ¿CORRECT,¿ BUT THE NP TOLD THE CONSUMER THEY WERE UNABLE TO FIX IT. THE NP WAS GOING TO TRY TO PROGRAM A NEW PP, BUT WAS UNABLE TO, AND WHEN THE CONSUMER GOT HOME THEY NOTICED THEIR PROGRAM WASN'T SHOWING UP ON THEIR SCREEN SO IT WAS RECOMMENDED TO CONTACT THE DOCTOR¿S OFFICE TO HAVE PROGRAMMING REINSTALLED INTO THE PP. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302800 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |