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

Model Number	DL-COIL BASE PART [D COIL-T BASE PART]
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.If it is returned to the manufacturer for evaluation a device failure analysis will be submitted as a follow up report.
Event or Problem Description
It was observed that the bottom of the dl-coil base part broke down after 3-6 months of use.To date no injury (i.E.Skin laceration) has been reported.The dl-coil was replaced.
Event or Problem Description
It was observed that the bottom of the dl-coil base part broke down after 3-6 months of use.The dl-coil had a #2 strength magnet.The dl-coil was replaced.No injury (i.E.Skin laceration) or skin irritation over the implant area has been reported.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed several mechanical damages on the top and bottom housing parts of the concerned device.Furthermore, the damage observed at the magnet locking mechanism is indicative of mechanical stress being applied to the device.These damages were possibly induced by inadvertent rough handling.No indication could be found that the device contributed to the found damages.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 8599033
• Report Number: 9710014-2019-00372
• Device Sequence Number: 19406550
• Product Code: MCM
• UDI-Device Identifier: 09008737313043
• UDI-Public: (01)09008737313043
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: DL-COIL BASE PART [D COIL-T BASE PART]
• Device Lot Number: SN: 011389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR