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

Model Number PULSAR

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 12/10/2017

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 stopped responding to sound with the device after a reported head trauma.No swelling was noted at the implant site.Re-implantation is being planned.

Manufacturer Narrative

Additional information: based on information and measurements received, a mechanical damage to the stimulator housing which is typical for a severe external impact to the housing appears likely.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Re-implantation is being considered, but no surgery date has been communicated.

Event Description

The recipient stopped responding to sound with the device after a reported head trauma.No swelling was noted at the implant site.Re-implantation is being planned.

Manufacturer Narrative

Conclusion: the device investigation revealed mechanical damage to the stimulator housing and electronics that is typical for severe external impact to the housing.The problems described in the recipient report and the reported accident appears to match the damage found.This is a final report.

Event Description

The recipient stopped responding to sound with the device after a reported head trauma.No swelling was noted at the implant site.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: 7147196
• MDR Text Key: 95917414
• Report Number: 9710014-2017-01106
• 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: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• 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: 07/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• 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: 6 YR