INTERSTIM
Report
- Report Number
- 3007566237-2018-00754
- Event Type
- Malfunction
- Date Received
- March 13, 2018
- Date of Event
- February 23, 2018
- Report Date
- May 4, 2018
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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.
ADDITIONAL INFORMATION WAS RECEIVED. MANUFACTURER REPRESENTATIVE REPORTED THE EVENT WAS RESOLVED. NO FURTHER COMPLICATIONS REPORTED/ ANTICIPATED.
INFORMATION WAS RECEIVED REGARDING A TRIAL PATIENT. MANUFACTURER REPRESENTATIVE REPORTED ON (B)(6) 2018 DURING A PNE TEST THE LEAD DID NOT PULL OUT OF LEFT SIDE OF THE PATIENT. AS THE HEALTH CARE PROFESSIONAL WAS PULLING OUT THE NEEDLE ALONG WITH THE STYLET, IT GOT STUCK. THE STYLET WOULD NOT COME OUT OF THE LEAD. IT WAS REPORTED THAT THEY TRIED TO TROUBLE SHOOT WAYS TO SAFELY AND SUCCESSFULLY PULL THE STYLET OUT OF THE LEAD BUT HAD NO SUCCESS. WE NEEDED TO PULL THE LEAD OUT ALONG WITH THE NEEDLE. IT HAD STRETCHED OUT DURING THEIR EFFORTS AND, IN THE END, THEY COULD NOT USE THAT LEAD. IT WAS REPORTED THAT THEY USED A REPLACEMENT PNE LEAD AND IT WORKED FINE. PROCEDURE ENDED WITH ZERO ADVERSE AFFECTS TO THE PATIENT. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176432 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | 3057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |