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U.S. Department of Health and Human Services

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

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MEDTRONIC XOMED, INC. SOPHONO® IMPLANT HEARING AID, BONE CONDUCTION Back to Search Results
Model Number S0521-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893)
Event Type  Death  
Manufacturer Narrative

Product evaluation: analysis results not available; device not returned for evaluation. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

During a communication in june 2016 between a medtronic international medical affairs staff member and the performing surgeon, additional information regarding patient outcome was obtained. It was reported to sophono that a patient who was already using an implant successfully on the right side since (b)(6) 2013, elected to receive an additional implant on the left side in (b)(6) 2014. The surgeon reported that both procedures were routine cases performed under general anesthesia. Approximately 15 - 20 minutes after surgery for the second implant, when the patient was in the recovery room, he started to complain of a headache, collapsed and lost consciousness. The patient was intubated and a ct scan confirmed a large intracranial bleed (sub-arachnoid hematoma) on the left side. The patient was then transferred to a neurosurgical hdu unit at another facility, still unresponsive. The additional information received in june of 2016 indicated that the patient ultimately expired. The performing surgeon confirmed there was no allegation against the device. Multiple attempts have been made to obtain additional information regarding this event. No further information is available at this time.

 
Manufacturer Narrative

Date of this report: 03/16/2016. Date manufacturer received: 01/05/2017. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameSOPHONO® IMPLANT
Type of DeviceHEARING AID, BONE CONDUCTION
Manufacturer (Section D)
MEDTRONIC XOMED, INC.
6743 southpoint drive north
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED, INC.
6743 southpoint drive north
jacksonville FL 32216
Manufacturer Contact
michelle alford
6743 southpoint drive north
jacksonville, FL 32216
9043328197
MDR Report Key5997900
MDR Text Key56403980
Report Number1045254-2016-00324
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK132189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2016
Device MODEL NumberS0521-02
Device Catalogue NumberS0521-02
Device LOT NumberP285462-00
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 Received02/24/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/09/2013
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: 10/04/2016 Patient Sequence Number: 1
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