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

Model Number PULSAR

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

Patient Problems Tissue Damage (2104); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and has been returned to (b)(4) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

An explanted device was received at hq for investigation.According the device explant report form, the wire was visible in the ear canal.

Manufacturer Narrative

Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.According to the patient report the device was explanted due to the active electrode extruded into the ear canal.The investigation results appear to match the problems mentioned in the patient report.Damages found during investigation are most likely due to explantation.This is a final report.

Event Description

Explanted device received at hq for investigation.Reportedly, the electrode lead extruded through the tympanic membrane in the external auditory canal.The extra cochlear position was present without any external influence.There was no decrease in hearing performance reported.According the device explant report form, the wire was visible in the ear canal.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 8205915
• MDR Text Key: 131699667
• Report Number: 9710014-2018-001049
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PULSAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR