MalfunctionNAM
URGENT PC NEUROMODULATION SYSTEM LEAD SET
Received Sep 13, 2021 · Event occurred Jul 19, 2021
Report MW5103878 · MDR key 12466867
Device
Generic name
Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction
Manufacturer
Laborie Medical TechnologiesModel number
REF UPC 250-12Lot number
104641
Product problems
- Loss of Power
Patient
80 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHEN APPLYING THE URGENT PC DEVICE TO THE PATIENT'S PTNS NEEDLE IN HER ANKLE THE URGENT PC DEVICE ONLY ALLOWED THE USER TO GO UP TO LEVEL 4 AND THEN TURNED OFF AUTOMATICALLY. DEVICE WAS PLUGGED IN AND BOTH LEADS DID THE SAME THING. WHEN SWITCHED TO AN ENTIRELY DIFFERENT LEAD, IT WORKED COMPLETELY FINE. FDA SAFETY REPORT ID# (B)(4).