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

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.

• Brand Name: SOPHONO® IMPLANT
• Type of Device: HEARING 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 Key: 5997900
• MDR Text Key: 56403980
• Report Number: 1045254-2016-00324
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: S0521-02
• Device Catalogue Number: S0521-02
• Device Lot Number: P285462-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death