MAUDE Adverse Event Report: MEDTRONIC XOMED INC. SOPHONO® RECHARGEABLE PROCESSOR

Model Number	S0821-02
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Response, Decreased (2271)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the internal device was no longer adhering to the external devices even with a 12 external plate.The patient had lost a device and even with a softband, the patient was no longer getting benefit.The device was scheduled to be removed.Additional information was received indicating that the patient had not been exposed to any strong magnetic fields and denied any head trauma as well.The health care provider performed numerous skin flap revisions and had concerns as the patient reported post-operative issues/pain even years after the procedure.The hcp noted that all options had been weighed carefully and the family and the team felt the best option for the patient was to remove the implant and use a different device.On follow-up, it was reported that the implant has been removed on (b)(6) 2019.

• Brand Name: SOPHONO® RECHARGEABLE PROCESSOR
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8359475
• Report Number: 1045254-2019-00103
• Device Sequence Number: 2306675
• Product Code: LXB
• UDI-Device Identifier: 00643169862234
• UDI-Public: 00643169862234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: Health Professional
• Device Model Number: S0821-02
• Device Catalogue Number: S0821-02
• Device Lot Number: 215191698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/21/2019
• 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