MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number SONATA

Device Problem Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

According to the information received from the field the recipient underwent a revision surgery due to pain over the implant site.Reportedly the pain was caused by the skin being to tight above the implant.During this surgery in (b)(6) 2018 the electrode array was inadvertently pulled out of cochlea, which was confirmed by diagnostic imaging.Thus, the concerned device was explanted and the recipient was re-implanted.The device is not available for investigation.This is combined initial and final report.

Event Description

In (b)(6) 2018 a repositioning surgery was performed because of complaints of pain around the area of the implant.According to the surgeon, the skin was too tight over the implant, causing the pain.In the original surgery, no implant bed was drilled.The patient had been a non-user for some time.After the surgery in situ measurements showed changes; the speech understanding scores were low.However, they were always low, even before repositioning surgery.Hence it was concluded that during the repositioning surgery the electrode array got inadvertently pulled out of the cochlea.The user was reimplanted a new device on (b)(6) 2019.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 8825656
• MDR Text Key: 152162700
• Report Number: 9710014-2019-00566
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR