MAUDE Adverse Event Report: DJO, LLC VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL; STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Model Number	2761
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Codes	Full thickness (Third Degree) Burn (2696); Lead(s), Burn(s) From (3161)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: unknown.The customer has not indicated that the device will be returned for evaluation.If the device is returned, a follow-up report will be submitted upon completion of the device evaluation.
Event or Problem Description
It was reported that the patient received a small 2cm x 0.8cm burn under an electrode.The patient was being treated for acute back pain using interferential current (ifc) with constant voltage (cv).Nursing was immediately notified, followed by a physician.The wound was cleansed by nursing, silvadene was applied, and the wound was covered by a non-stick gauze, changed twice a day.The patient was monitored at a skilled nursing facility for signs and symptoms of infection.No further information is available.

• Brand Name: VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
• Common Device Name: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8503356
• Report Number: 9616086-2019-00015
• Device Sequence Number: 13508553
• Product Code: GZI
• UDI-Device Identifier: 00888912292849
• UDI-Public: 00888912292849
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68