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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(exemption number e2015033).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 or Problem Description
Hearing performance with the device is affected.During a speech therapy session on (b)(6) 2018, the user was unable to repeat ling sounds.There was no report of a head injury.The parent noticed that difficulties with hearing started that day.
Additional Manufacturer Narrative
Med-el elektromedizinische geraete (b)(4) and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.The problems given in the recipient report appear to match the damage found.Further, two channels involved in a short circuit were present since december 2017.Therefore one channel was deactivated.This is a final report.
Event or Problem Description
Hearing performance with the device is affected.There was no report of a head injury.The parent noticed that difficulties with hearing started that day.
Additional Manufacturer Narrative
Med-el elektromedizinische geraete (b)(4) and vibrant med-el submit mdr reports on behalf of med-el corporation (exemption number e2015033).Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.Furthermore, in situ measurements show two channels involved in a short circuit since (b)(6) 2017 due to undetermined reasons.Therefore one channel was deactivated.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is planned for (b)(6) 2019.
Event or Problem Description
Hearing performance with the device is affected.There was no report of a head injury.The parent noticed that difficulties with hearing started that day.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 8114923
• Report Number: 9710014-2018-00967
• Device Sequence Number: 1487185
• Product Code: MCM
• UDI-Device Identifier: 09008737093983
• UDI-Public: (01)09008737093983(
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 11/12/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/20/2019; 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR