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

Model Number	2786
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been no reported patient injury or harm at this time.Device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that "the unit was shocking patients." device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

• 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: 10575069
• Report Number: 9616086-2020-00030
• Device Sequence Number: 16461442
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1