VECTRA GENISYS E - STIM 2761

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for VECTRA GENISYS E - STIM 2761 manufactured by Djo, Llc.

Event Text Entries

[118871728] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079457
MDR Report Key7826455
Date Received2018-08-28
Date of Report2018-08-21
Date of Event2018-08-15
Date Added to Maude2018-08-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVECTRA GENISYS E - STIM
Generic NameSTIMULATOR, MUSCLE, POWERED
Product CodeNGX
Date Received2018-08-28
Model Number2761
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-28

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