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

Model Number SONATA

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913); Electrical Shorting (2926)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Since (b)(6) 2013, the patient progressively got more electrode channels in status high and a pair of short circuit electrodes.The patient has managed to use 5-6 electrodes for a couple of years but now he has only 2 active electrodes.Re-implantation is planned but a date has not been set yet.

Manufacturer Narrative

(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Manufacturer Narrative

Conclusion: damage to the active electrode likely caused by minute device mobility was determined to have led to device failure over time.The investigation results appear to match the problems mentioned in the patient report.This is a final report.

Event Description

Since (b)(6) 2013, the patient progressively got more electrode channels in status high and a pair of short circuit electrodes.The patient has managed to use 5-6 electrodes for a couple of years but now he has only 2 active electrodes.The patient has been re-implanted.

• 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: 4913087
• MDR Text Key: 6432197
• Report Number: 9710014-2015-00499
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Other Device ID Number: (01) 09008737042134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 63 YR