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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. SOPHONO® HEARING AID, BONE CONDUCTION

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MEDTRONIC XOMED INC. SOPHONO® HEARING AID, BONE CONDUCTION Back to Search Results
Model Number UNK SOPHIMPL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Impaired Healing (2378); Fluid Discharge (2686)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative

Product evaluation: analysis results are not available; the device was not returned for evaluation. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient had a sophono implant surgically placed. ¿the incision site healed up nicely post-operatively. Two weeks later, the patient felt discomfort at the site; there was swelling, and the wound had opened and drained, and the patient had irritation at the wound site. It was cleaned out and since it did not drain, hyperbaric treatments were used to heal the wound site. There was no infection present. The audiologist noted that the patient's skin thickness and [elasticity] was that of an older person in that in pulls apart easily, hard to stay closed, popped, and gave away. At this time, the audiologist does not believe that the event is related to an allergy. Plastic surgery was used to re-seal the wound site since it was not staying closed. The surgeon and audiologist would like to wait a few extra weeks to follow-up with the patient and make sure all the tissue is okay. Then the patient will be fitted with the sophono processor. ¿.

 
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Brand NameSOPHONO®
Type of DeviceHEARING AID, BONE CONDUCTION
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer Contact
uriza shums
6743 southpoint drive north
jacksonville, FL 32216
9043328405
MDR Report Key7393534
MDR Text Key104213012
Report Number1045254-2018-00147
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 AUDIOLOGIST
Type of Report Initial
Report Date 04/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK SOPHIMPL
Device Catalogue NumberUNK SOPHIMPL
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 Received03/07/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/03/2018 Patient Sequence Number: 1
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