INTELECT XT 2CH COMBO

Description of Event or Problem

THE PATIENT RECEIVED A SKIN BLISTER ON THE LOWER BACK, LESS THAN 1CM IN SIZE, DURING AN INTERFERENTIAL ELECTROTHERAPY TREATMENT. THE PATIENT HAD RECEIVED ELECTROTHERAPY TREATMENT FOUR TIMES PREVIOUS TO THIS EVENT. THE TREATMENT WAS APPLIED WITH SELF ADHESIVE 2.75 INCH DIAMETER ELECTRODES THAT HAD ALSO BEEN USED IN THE FOUR PREVIOUS TREATMENTS. THE PATIENT'S SKIN WAS PREPPED WITH WATER. THE INTERFERENTIAL TREATMENT WAVEFORM WAS SET TO CONSTANT CURRENT AND THE INTENSITY WAS SET TO 15-18 MA. THE PATIENT COMPLETED THE 15 MINUTE TREATMENT WITH NO NOTED DISCOMFORT. UPON COMPLETION OF THE TREATMENT, THE CLINICIAN DID NOT NOTE ANY INJURY IN THE TREATMENT AREA. THE FOLLOWING DAY, THE PATIENT REPORTED A SINGLE BLISTER WERE ONE OF THE TREATMENT ELECTRODES HAD BEEN PLACED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION FOR THE INJURY AND THEIR PROGRESS WAS NOT IMPEDED. PATIENT ONE OF FOUR.

Description of Event or Problem

THE PATIENT RECEIVED A SKIN BLISTER DURING AN ELECTROTHERAPY TREATMENT USING THE PREMOD WAVEFORM. THE CLINICIAN DID NOT SPECIFY ELECTRODE, INJURY, TREATMENT, OR PATIENT DETAILS. UPON THE COMPLETION OF THE TREATMENT, THE CLINICIAN DID NOT NOTE ANY INJURY IN THE TREATMENT AREA. THE FOLLOWING DAY, THE PATIENT REPORTED A SINGLE BLISTER WHERE ONE OF THE TREATMENT ELECTRODES HAD BEEN PLACED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION FOR THE INJURY AND THEIR PROGRESS WAS NOT IMPEDED.

Description of Event or Problem

THE PATIENT RECEIVED A SKIN BLISTER ON THE KNEE DURING AN ELECTROTHERAPY TREATMENT USING THE INTERFERENTIAL WAVEFORM. THE CLINICIAN DID NOT RECALL ALL ELECTRODE, INJURY, TREATMENT, OR PATIENT DETAILS. UPON THE COMPLETION OF THE TREATMENT THE CLINICIAN NOTED A SINGLE BLISTER APPROXIMATELY 1 INCH IN DIAMETER WHERE ONE OF THE TREATMENT ELECTRODES HAD BEEN PLACED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION FOR THE INJURY AND THEIR PROGRESS WAS NOT IMPEDED. PATIENT FOUR OF FOUR.

Description of Event or Problem

THE PATIENT RECEIVED A SKIN BLISTER ON THE FOOT DURING AN ELECTROTHERAPY TREATMENT USING THE INTERFERENTIAL WAVEFORM. THE CLINICIAN DID NOT RECALL ALL ELECTRODE, INJURY, TREATMENT, OR PATIENT DETAILS. UPON THE COMPLETION OF THE TREATMENT, THE CLINICIAN NOTED A SINGLE BLISTER WHERE ONE OF THE TREATMENT ELECTRODES HAD BEEN PLACED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION FOR THE INJURY AND THEIR PROGRESS WAS NOT IMPEDED. PATIENT THREE OF FOUR.

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.