MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH PULSAR; COCHLEAR IMPLANT

Model Number PULSAR

Device Problem Impedance Problem (2950)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been explanted and has been returned to med-el hq 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.According to the device explantation report the device has been explanted due to electrode defects.

Manufacturer Narrative

Conclusion: investigation revealed damage to the electrode pins likely caused by repeated external mechanical impacts on the device.The problems described in the recipient report appear to match the damage found.This is a final report.

Event Description

An explanted device was received at hq.According to the device explantation report the device has been explanted due to electrode defects.The user has been re-implanted.

• Brand Name: PULSAR
• 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: 19048939
• MDR Text Key: 340038540
• Report Number: 9710014-2024-00324
• 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
• Report Date: 05/10/2024

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: Lay User/Patient
• Device Model Number: PULSAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 05/10/2024
• 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: 21 YR
• Patient Sex: Female