MAUDE Adverse Event Report: DJO, LLC COMPEX SET WIRELESS SP8.0 MULTILINGUAL EU PLUG; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number 2539116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the user suffered an epileptic seizure.Patient had earlier suffered from a cerebral haemorrhage and has been paralyzed.It is the son of the user who has controlled the device.Further information was requested but is not available.

• Brand Name: COMPEX SET WIRELESS SP8.0 MULTILINGUAL EU PLUG
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJO TUNISIE; zone industrielle poudriere 1; aout; sfax, 3002 ; TS 3002
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9529957
• MDR Text Key: 173301632
• Report Number: 3007615436-2019-00004
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 12/30/2019

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: 2539116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/30/2019
• 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