MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Model Number C40+

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Tissue Breakdown (2681)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

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 audiologist reported that the user complained of pain at implant site in (b)(6).The magnet strength on dl-coil was reduced to #1.Then the user's daughter sent pictures to the clinic at the end of (b)(6), showing that the receiver stimulator had started extruding through the skin.The user was advised not to wear the device and topical medication was prescribed.There were some signs of infection.

Manufacturer Narrative

Conclusions: device investigation did not reveal any device defect or damage which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received the device extruded through the skin causing an infection.Reportedly also the magnet strength and recent weight lost might have contributed to the observed issue.However this could not be confirmed.The remainder part of the active electrode and reference electrode have been received, no abnormalities found during investigation.Damages found during device investigation are most likely related to the explantation surgery.This is a final report.

Event Description

The user complained of pain at implant site in (b)(6) 2020.The magnet strength on dl-coil was reduced to 1.The receiver stimulator started extruding.The user has been re-implanted with a new device on (b)(6) 2020.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10009207
• MDR Text Key: 190925795
• Report Number: 9710014-2020-00241
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR