MAUDE Adverse Event Report: DJO, LLC SET WIRELESS SP6.0 MULTILINGUAL US PLUG; POWERED MUSCLE STIMULATOR

Model Number 2538660

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Seizures (2063)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

The device was received and a follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient started to have subtle seizures after a couple days of using the device.The patient's doctor explained to the patient that he was having epileptic seizures and advised him to stop using the device immediately.The seizures involved an involuntary slight turn on his head, blink of his eye, and then a feeling that he was about to faint.After this, he experienced headaches that could last for an hour.The device labeling states "epilepsy.If you have suspected or diagnosed epilepsy, you should follow the precautions for use recommended by your doctor.".

Manufacturer Narrative

The device was received and evaluated.It was put through 10 hours of use.There was no fault found with the device.The device labeling states, "epilepsy.If you have suspected or diagnosed epilepsy, you should follow the precautions for use recommended by your doctor.".

• Brand Name: SET WIRELESS SP6.0 MULTILINGUAL US PLUG
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): DJO, LLC; 3151 scott street; vista CA 92081 9663
• MDR Report Key: 8223328
• MDR Text Key: 132264034
• Report Number: 3007615436-2019-00001
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• PMA/PMN Number: K143551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2538660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability