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

Model Number PULSAR

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Head Injury (1879); Failure of Implant (1924)

Event Date 06/20/2015

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

It was reported that the patient suffered an impact to the head that caused damage to the device.Thereafter, the patient has been re-implanted.

Manufacturer Narrative

Additional information: based on the received information, the implant housing was damaged due to an accident.The device has not been received for investigation.The complaint can be re-opened when the device is available for investigation.

Event Description

It was reported that the patient suffered an impact to the head that caused damage to the device.The patient has been re-implanted.

Manufacturer Narrative

The device investigation revealed mechanical damage to the stimulator housing that is typical for severe external impact to the housing.The problems described in the recipient report appear to match the damage found.This is a final report.

Event Description

It was reported that the recipient had an impact to the head that caused damage to the device.The recipient underwent re-implantation surgery on (b)(6) 2015.

• 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: 5027041
• MDR Text Key: 23908658
• Report Number: 9710014-2015-00595
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PULSAR
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• 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: 17 YR