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

Model Number 2761

Device Problem Electrical Overstress (2924)

Patient Problems Full thickness (Third Degree) Burn (2696); Lead(s), Burn(s) From (3161)

Event Date 02/07/2019

Event Type  Injury  

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 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
• Type of Device: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8503356
• MDR Text Key: 141579532
• Report Number: 9616086-2019-00015
• Device Sequence Number: 1
• Product Code: GZI
• UDI-Device Identifier: 00888912292849
• UDI-Public: 00888912292849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68