MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA LEGEND XT 4CH STIM PKG US STD; STIMULATOR, MUSCLE, POWERED

Model Number	2786
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that during a treatment, the intensity rose up to 30ma and then immediately shut off".There was no reported patient harm.No further information is currently available.

• Brand Name: CHATTANOOGA LEGEND XT 4CH STIM PKG US STD
• Common Device Name: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• MDR Report Key: 9519379
• Report Number: 9616086-2019-00087
• Device Sequence Number: 491509
• Product Code: IPF
• UDI-Device Identifier: 00888912294140
• UDI-Public: 00888912294140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1