INTELECT XT 2CH COMBO
Received May 27, 2009
Report 1022819-2009-00131 · MDR key 1394843
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
16 YR
- Electric Shock
Narrative
Description of Event or Problem
THE PATIENT COMPLAINED OF A SHOCK SENSATION DURING AN INTERFERENTIAL ELECTROTHERAPY TREATMENT TO THE KNEE. THE CLINICIAN PRESCRIBED THE INTERFERENTIAL ELECTROTHERAPY WAVEFORM WITH A TREATMENT TIME OF 15 MINUTES AND SET TO AN INTENSITY OF 8-10MA. THE TREATMENT WAS APPLIED WITH 2X4 INCH ELECTRODES THAT HAD BEEN APPLIED 3 OR 4 TIMES PRIOR TO THIS EVENT. THE CLINICIAN APPLIED THE TREATMENT AND LEFT THE PATIENT FOR A BRIEF MOMENT. IN THE LAST FEW SECONDS OF THE TREATMENT, THE PATIENT COMPLAINED OF RECEIVING A SHOCK FROM THE DEVICE. THE PATIENT WAS NOT INJURED. NO MEDICAL TREATMENT WAS REQUIRED FROM THE EVENT.
Additional Manufacturer Narrative
A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS.