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

Model Number PULSAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2017

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 patient fell and hit her head on the floor.After that, she no longer had access to sound using the device and reports feeling pain on the implant area.

Manufacturer Narrative

Conclusion: according to the currently available information, the recipient lost access to sound with the device after an impact at the implant site.However, despite requested no further information or any in situ measurements have been received and no device investigation is possible at this time.Therefore, currently available information does not allow identifying a specific root cause.Additionally, the recipient reports pain around the implant area after the impact.A decision regarding explantation surgery has not been made available yet.

Event Description

The recipient fell and hit her head on the floor.After that, she no longer had access to sound using the device and reports feeling pain on the implant area.Further proceedings are unknown.Despite requested, further information was not received.

Manufacturer Narrative

Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The active electrode also showed some additional damage to the electrode wires, as caused by minute device mobility.The reported impact might have weakened the fixation of the implant, consequently leading to electrode mobility.In addition, pain and a migrated electrode array was reported, which is most likely a result of the reported trauma.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The recipient fell and hit her head on the floor.After which, she no longer had access to sound using the device and reported feeling pain at the implant area.The recipient was re-implanted.

• 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: 7127979
• MDR Text Key: 95251078
• Report Number: 9710014-2017-01074
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

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
• Device Operator: Health Professional
• Device Model Number: PULSAR
• Other Device ID Number: (01) 09008737030421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/08/2017; 12/08/2017
• Supplement Dates FDA Received: 03/19/2018; 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 7 YR