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

Device Problems Circuit Failure (1089); High impedance (1291); Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The pt does not like to wear the external processor.In situ measurements show only two active channels, the rest have high impedance or are involved in a short circuit.Re-implantation will likely take place but a date has not been scheduled.Further info states that the pt has fell a few times but not directly hitting the head or implant.

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, 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

The patient does not like to wear the external processor.Further information states that the patient has fallen a few times but not directly hitting the implant area.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: CONCERTO PIN
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck, tirol ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck, tirol A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4662180
• MDR Text Key: 22060509
• Report Number: 9710014-2015-00257
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• 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: 06/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2015
• 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