MAUDE Adverse Event Report: DJO, LLC COMPEX; COMPEX WIRELESS USA COMPLETE SET

Model Number	2540660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Plaintiffs counsel claims in the complaint that "electrode stimulation proved to be dangerously high, causing mr.(b)(6)'s bicep to forcefully and unnaturally contract to a dangerous degree and proceeded to injure our client.Impression: rotator cuff tendinosis with mild intrasubstance partial tearing.There is no full thickness tear present.Mild subacromial and subdeltoid bursitis.There is a complete tear of the biceps tendon with the proximal portion of the biceps extending anteriorly and superior to the subscapularis muscle bundle.Superior labral tearing.Glenohumeral joint effusion.Acromioclavicular joint hypertrophy and inflammation".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: COMPEX
• Common Device Name: COMPEX WIRELESS USA COMPLETE SET
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6697220
• Report Number: 9616086-2017-00011
• Device Sequence Number: 1078158
• Product Code: NGX
• UDI-Device Identifier: 00888912290463
• UDI-Public: 00888912290463
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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
• Operator of Device: Other
• Device Model Number: 2540660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other