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 Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reported that signs of pressure could be seen on the bottom of the dl-coil and d coil base parts from where the magnet is pressing against it.There has been no injury reported.
Additional Manufacturer Narrative
Conclusion: dl-coil base part investigation confirmed the presence of a round crack, which is most likely attributable to inadvertent misuse, e.G.By usage of an incorrect coil cover or by the magnet being pressed rather than turned into the base part.It is considered unlikely that the device was damaged during a magnet exchange as overwinding is prevented by design.This is a final report.
Event or Problem Description
It was reported that signs of pressure could be seen on the bottom of the dl-coil and d coil base parts from where the magnet is pressing against it.From photos received, it appears the pressure of the magnet in the dl-coil has caused the base part to crack.The d-coil shows only some light signs of pressure where the magnet touches and a circle is seen on the base part.The base part of the d-coil however is not broken.As per additional information, the recipient uses dl-coil magnets with strength 4 or 5 with regular coils.There has been no injury.These external components were exchanged for precaution.

• 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: 7925080
• Report Number: 9710014-2018-00761
• Device Sequence Number: 19262912
• Product Code: MCM
• UDI-Device Identifier: 09008737313043
• UDI-Public: (01)09008737313043
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/23/2019

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: 007510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR