MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; MI1000 CONCERTO

Device Problem No Device Output (1435)

Patient Problems Bruise/Contusion (1754); Head Injury (1879)

Event Type  Injury  

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.

Event Description

The patient had a head trauma on the left side.The in situ measurements showed 4 electrode channels in status hi but the hearing performance was still good.In (b)(6) 2015, the patient had a trauma again which caused a bruise on the anterior line of the magnet.The measurements performed showed the same results as before and the patient was hearing.Now the patient reports no more hearing sensation at all.

Manufacturer Narrative

Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.Device investigation also showed damage to the active electrode, which is typical for minute device mobility.It is assumed that this might be related to the reported accidents and falls, which reportedly occurred overtime.The problems given in the patient report appear to match the damage found.This is a final report.

Event Description

The patient hearing sensation deteriorated.The patient had a head trauma on the left side.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: MI1000 CONCERTO
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4963721
• MDR Text Key: 22422649
• Report Number: 9710014-2015-00540
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• 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: 34 MO