FDA Adverse Event Other Summary report: N

INTELECT LEGEND STIM

MDR report key: 1016333 · Received March 21, 2008

Report

Report Number: 1022819-2008-00104
Event Type: Other
Date Received: March 21, 2008
Date of Event: March 14, 2008
Report Date: March 20, 2008
Manufacturer: CHATTANOOGA GROUP
Product Code: GZJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AWAITING RETURN AND EVALUATION OF THE DEVICE. TYPE OF DEVICE: IPF, STIMULATOR, MUSCLE, POWERED, 890.5858; GZI, STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL, 882.5810.

Description of Event or Problem · 1

THE PATIENT RECEIVED BURNS IN THE LOWER BACK ARE DURING AN ELECTROTHERAPY TREATMENT USING CARBON ELECTRODES. THE CLINICIAN TREATED THE PATIENT USING THE INTERFERENTIAL WAVEFORM (IFU). THE OUTPUT INTENSITY APPLIED TO THE PATIENT WAS ESTIMATED TO BE AT 38MA, MODULATED AT 80 TO 150 HZ. THE TREATMENT TIME FOR THE PATIENT UNDER THIS PRESCRIBED TREATMENT WAS FOR 20 MINUTES. THE PATIENT COMPLETED THE 20 MINUTE TREATMENT WITH NO ISSUES OR NOTED DISCOMFORT. NO UNUSUAL CHARACTERISTICS WERE NOTED IN THE AREA OF THE TREATMENT. THE FOLLOWING DAY THE PATIENT NOTIFIED THE CLINIC, INFORMING THEM OF THE BURN(S). THE PATIENT REPORTED HAVING ONE FIRST DEGREE BURN AND ONE SECOND DEGREE BURN IN THE TREATMENT AREA OF THE ELECTRODES. BOTH BURNS WERE APPROXIMATED TO BE ABOUT 1/4" IN DIAMETER. THE PATIENT DID NOT REQUIRE ANY POST TREATMENT MEDICAL CARE FOR THE RESULTANT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTELECT LEGEND STIM	GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF, 882.5810	GZJ	CHATTANOOGA GROUP	INT002

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other