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U.S. Department of Health and Human Services

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

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MEDTRONIC XOMED INC. SOPHONO® RECHARGEABLE PROCESSOR Back to Search Results
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.

 
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Brand NameSOPHONO® 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 Key8359475
MDR Text Key136843556
Report Number1045254-2019-00103
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberS0821-02
Device Catalogue NumberS0821-02
Device LOT Number215191698
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/04/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/21/2019 Patient Sequence Number: 1
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