LEGEND XT 2 CH STIM
Received Oct 6, 2008 · Event occurred Apr 29, 2008
Report 1022819-2008-00153 · MDR key 1190302
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Electric Shock
Narrative
Description of Event or Problem
THE PT REC'D A JOLT SENSATION AT THE BEGINNING OF AN ELECTROTHERAPY TREATMENT. THE PT WAS RECEIVING ELECTROTHERAPY TREATMENT IN THE AREA OF THE CALF MUSCLE. THE CLINICIAN STARTED THE TREATMENT, AND THE PT BEGAN COMPLAINING OF A JOLTING SENSATION NON-TYPICAL OF AN ELECTROTHERAPY TREATMENT. THE CLINICIAN TERMINATED THE TREATMENT. THE CLINICIAN PRESCRIBED THE RUSSIA WAVEFORM FOR THE ELECTROTHERAPY TREATMENT. THE OUTPUT OF THE WAVEFORM WAS DETERMINED TO BE LESS THAN .1 WHEN THE EVENT OCCURRED. THE TREATMENT TIME WAS PRESCRIBED TO BE 15 MINS. THE CLINICIANS APPLIED THE TREATMENT USING SELF ADHESIVE ELECTRODES. THE ELECTRODES FOR THIS PT HAD BEEN USED LESS THAN 5 TIMES PRIOR TO THIS INCIDENT. THE ELECTRODE SIZE WAS 2X2 INCHES. THE PT DID NOT RECEIVE AN INJURY AS A RESULT OF THE INCIDENT. THE PT HAD REC'D ELECTROTHERAPY TREATMENT WITHOUT REPORTED ISSUE PRIOR TO THIS EVENT. THE CLINICIAN DID REPORT THAT THE DEVICE HAD TO HAVE THE POWER RECYCLED EARLIER. AFTER THE POWER WAS RECYCLED, THE DEVICE OPERATED WITHOUT ISSUES.
Remedial action
- Recall