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

Model Number	01-207-0007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Increased Sensitivity (2065)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient "has metal beads from her lynx procedure and used her spinalogic stim once and felt a painful pull." it was then clarified that the patient "did not have any permanent damage from the use of the device and the use of the device was discontinued immediately but that there may have been possible permanent damage to the patient if the use of the device was continued.".
Event or Problem Description
It was reported that the patient "has metal beads from her lynx procedure and used her spinalogic stim once and felt a painful pull." it was then clarified that the patient "did not have any permanent damage from the use of the device and the use of the device was discontinued immediately but that there may have been possible permanent damage to the patient if the use of the device was continued.".
Additional Manufacturer Narrative
H2, h3, h6: device was returned for evaluation.Ran full treatment at test station with magnetometer: observed results within specifications.Device performed as expected; could not duplicate reported event, no failure identified.It was found that the device had never been used for treatment (a blank treatment log was found during device evaluation).

• Brand Name: CMF SPINALOGIC
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9957500
• Report Number: 3012446970-2020-00013
• Device Sequence Number: 3435128
• 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): 07/26/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 01-207-0007
• Device Catalogue Number: 01-207-0007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR