MAUDE Adverse Event Report: DJO LLC VECTRA GENISYS; STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Model Number	2761
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Burn(s) (1757); Electric Shock (2554)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the unit allegedly shocked and caused a burn to patient during treatment.Enovis has received sufficient information regarding the reported burn the degree of burn is unknown and medical intervention was required.Patient was treated with antibiotic cream and a band aid.After performing functional and electrical testing, the technician was unable to duplicate the reported complaint.The product met manufacturer specifications.
Event or Problem Description
It was reported that the unit allegedly shocked and caused a burn to patient during treatment.

• Brand Name: VECTRA GENISYS
• Common Device Name: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 16026891
• Report Number: 9616086-2022-00032
• Device Sequence Number: 20631424
• Product Code: GZI
• UDI-Device Identifier: 00888912292849
• UDI-Public: 00888912292849
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 27335 SERIAL (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown