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

Model Number	01-207-0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Pain (1994)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.If the device becomes available, a follow-up report will be submitted upon completion of evaluation.
Event or Problem Description
It was reported that usage of the device during treatment altered the patient's heart rate.At the 1st treatment, after about three minutes, her heart skipped a beat and started pounding.She took off the device and her rapid heartbeat lasted about thirty minutes.When she tried her second treatment, she felt like pins and needles were stabbing her.The patient was advised to stop any use of the device immediately and call her physician.The patient's physician advised the patient to discontinue use.The patient has had a double bypass and stents were put in.She also has a wire around her sternum.
Additional Manufacturer Narrative
One spinalogic (part number 01-207-0007, serial number (b)(4) was returned for evaluation.Testing of the device included full treatment at a test station with results observed to be within specifications.The reported event could not be duplicated; no failure was identified.

• Brand Name: CMF SPINALOGIC
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8582060
• Report Number: 3012446970-2019-00012
• Device Sequence Number: 1858212
• Product Code: LOF
• UDI-Device Identifier: 00888912011495
• UDI-Public: 00888912011495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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
• 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: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: Required Intervention