MAUDE Adverse Event Report: DJO, LLC CMF; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	01-207-0007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint received that alleges "when 1st got the device there was no issues using it, but on (b)(6) 2018 she got a shock while using the device & was in pain.Said she has gone to the emergency room (er) & was informed that she has titanium rods implanted & so the magnetic waves was causing the shocks to her body.Said she also talked to her dr & dr has informed her to stop using the device.Patient states has not used the device since (b)(6) 2018 but is still getting shocks inside her body".
Additional Manufacturer Narrative
The device was returned for evaluation.Full treatment was ran at a test station and observed results were within specifications.A quality assurance technician wore the device for a full 30 minute treatment with no shocks, pain, or discomfort during or after treatment.The reported event could not be duplicated.The device performed as expected with no failure identified.

• Brand Name: CMF
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO, LLC; 1460 decision street; vista CA 92081 9663
• MDR Report Key: 7690879
• Report Number: 3012446970-2018-00005
• Device Sequence Number: 19034099
• Product Code: LOF
• UDI-Device Identifier: 00888912011495
• UDI-Public: 00888912011495
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 01-207-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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