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

Model Number S0821-02

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8359475
• MDR Text Key: 136843556
• Report Number: 1045254-2019-00103
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 00643169862234
• UDI-Public: 00643169862234
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: S0821-02
• Device Catalogue Number: S0821-02
• Device Lot Number: 215191698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/21/2019
• Date Device Manufactured: 04/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention