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 Problems Failure of Implant (1924); No Information (3190)

Event Date 12/05/2017

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 was seen for a regular follow-up.In situ measurements taken showed some affected channels.It is unknown if hearing performance is affected.There is no report of accident or trauma.Surgeon will be consulted.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.Surgical evaluation is scheduled for (b)(6)2018.

Event Description

The recipient was seen for a regular follow-up.In situ measurements taken showed some affected channels.It was unknown if hearing performance is affected.Per new information received, hearing performance has not been affected.There is no report of accident or trauma.There have been no changes in health.Mri has been recommended.Recipient is scheduled for surgical evaluation in (b)(6) 2018.

Manufacturer Narrative

Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The recipient was seen for a regular follow-up.In situ measurements carried out showed some affected channels.The hearing performance had reportedly not been affected.There is no report of accident or trauma.There have been no changes in health.Re-implantation was performed.According to the device explantation report, the ground electrode tip was damaged during removal.

• 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: 7147222
• MDR Text Key: 95917328
• Report Number: 9710014-2017-01107
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 02/06/2019

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: 01/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2017
• 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: 4 YR