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

Model Number MI1000 MED-EL CONCERT

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Hearing Impairment (1881); Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the pt's mother reported that the child does not react to speech from a distance that well as she did in the past and that she does not react to speech if only the right audio processor is active.The child complains immediately if the left audio processor is taken off but not when the right audio processor is inactive.The mother could not see any hits or injuries around the implanted site as long as the child was under her care, the child already goes to kinder garden.In situ measurements showed all channels with status hi except for channel revision surgery is considered.

Manufacturer Narrative

Udi#: (b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for eval.When available, a device failure analysis will be submitted as a f/u report.

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.The problems given in the patient report appear to match the damage found.This is a final report.

Event Description

It was reported by the patient's mother that the child does not react to speech from a distance as well as she did in the past and that she does not react to speech if only the right audio processor is active.The child complains immediately if the left audio processor is taken off but not when the right audio processor is inactive.The mother did not see any sign of trauma around the implanted site whilst the child was under her care, the child also attends kindergarten.

• 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: 4766211
• MDR Text Key: 5793760
• Report Number: 9710014-2015-00329
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737062682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2015
• 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: 26 MO