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

Model Number MI1200 SYNCHRONY PIN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Skin Inflammation (2443)

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 was seen for a follow-up visit and in situ measurements showed all channels with high impedance.Previous in situ measurements showed normal results.Further tests have been scheduled.

Manufacturer Narrative

(b)(4).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 was seen for a follow-up visit and in-situ measurements showed all channels with high impedance.Previous in-situ measurements showed normal results.The parent reported that no significant incident of accident or trauma was noted by family or day-care providers.The contralateral device also stopped working around the same time.The patient was bilaterally 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: 5747522
• MDR Text Key: 48096829
• Report Number: 9710014-2016-00406
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Other Device ID Number: (01) 09008737094010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• 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: 30 MO