MAUDE Adverse Event Report: DJO, LLC VECTRA GENISYS E - STIM; STIMULATOR, MUSCLE, POWERED

Model Number 2761

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Tingling (2171)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

At approx 1:45 pm, this individual was receiving therapy at isle health and rehabilitation in (b)(6).An e-stim was being used on her left shoulder to her right knee, concurrently.When the e-stim was activated, an increased shock was felt to her left arm with sharp shooting pain traveling up to her neck and down to her fingertips.The shock jerked her arm upward and she yelled out.Once the e-stim was turned off, the sharp pain ceased, but her left arm was still stiff and tingling.This was reported immediately and the e-stim was taken out of service, and now sequestered indefinitely.Medquip and djo are aware.Relevant therapy note: "estim was applied to l shoulder and r knee in order to decrease pain.Parameters: interferential current, cv, 4000 hz, 80/150 hz, automatic vector scan, 40%.Shoulder - 5.8 volts x 13 mins, knee 6.8 volts x 10 mins.Pt reported severe shooting pain / l shoulder.As per pt, "electric shock pain - l hand to the neck." discontinued electrical stimulation treatment immediately and applied cryotherapy to l shoulder and neck in order to decrease acute pain.Pt reported 7/10 pain after the treatment today.No change in skin condition after or before application of estim or after surge." dates of use: (b)(6) 2018, (b)(6) 2018.Diagnosis or reason for use: work related injuries to shoulder and knee.

• Brand Name: VECTRA GENISYS E - STIM
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO, LLC ; 1430 decision st; vista CA 92081
• MDR Report Key: 7826455
• MDR Text Key: 118871728
• Report Number: MW5079457
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2018

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
• Device Operator: Health Professional
• Device Model Number: 2761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 91