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

Device Problems No Device Output (1435); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hearing Impairment (1881)

Event Date 03/16/2015

Event Type  Injury  

Event Description

It was reported that the patient had not returned to the clinic for about 1 year.Patient's mother made an appointment because the patient had not been wearing the processor for a few months since her teachers said she cannot hear from it.There was no specific head trauma noted, although her mother did note that she suffered a significant seizure in (b)(6) and required hospitalization.

Manufacturer Narrative

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

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 pt report appear to match the damage found.This is a final report.

Event Description

It was reported that the pt had not returned to the clinic for about 1 year.Pt's mother made an appointment because the pt had not been wearing the processor for a few months since her teachers said she cannot hear from it.There was no specific head trauma noted, although her mother did note that she suffered a significant seizure in november and required hospitalization.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: MED-EL CONCERT
• 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: 4688029
• MDR Text Key: 5670584
• Report Number: 9710014-2015-00252
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• 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: 5 YR