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

Model Number C40+

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Headache (1880); Failure of Implant (1924)

Event Date 08/12/2020

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 user reported a sudden onset of shocking sensation at the implant site on (b)(6) 2020 and stated that she could not hear using her audio processor, therefore she removed it immediately and she did not wear it for the rest of the weekend.

Event Description

The user reported a sudden onset of shocking sensation at the implant site on (b)(6) 2020 and stated that she could not hear using her audio processor, therefore she removed it immediately and she did not wear it for the rest of the weekend.She also reported experiencing a headache when using the device.Reportedly, the shocking sensation occurs only when the device is in use.She stated that she hears a "buzzing" sound with the audio processor on and off but is more amplified when the processor is on.She reports that the buzzing sound seems to interfere with her speech understanding.She hears the buzzing with her opus 2 processor but feels that it is worse when using the loaner sonnet provided by the clinic.The headache/head pain has continued, and she feels as though her head is foggy, and she cannot focus.The user was re-implanted on (b)(6) 2020.Latest information of 28 april 2021 states that no further symptoms have been reported.

Manufacturer Narrative

Conclusions: device investigation did not reveal any device defect or damage, which might have been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received, the recipient experienced shocking sensations when using the device.Further, pain to the head and "buzzing" sound were reported, also when the device was not in use, but the latter was amplified when the processor was on.However, no device failure was found during investigation, which could explain the reported symptoms.The latter might represent delayed post-operative known side effects of cochlear implantation.This is a final report.

• 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: 10452548
• MDR Text Key: 204345456
• Report Number: 9710014-2020-00450
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR