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

Model Number PULSAR

Device Problems Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the pt was a good performer in the beginning, but after a while, performance was fluctuating.After many fitting attempts and medical investigations, nothing was found or improved.Recently, the pt suffered from severe pain in the implanted ear while using the audio processor.Therefore, the pt stopped using the device.

Manufacturer Narrative

Udi code not available for this device.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.

Manufacturer Narrative

Conclusion: device investigation showed damage to the active electrode lead caused by a sharp instrument.This is compatible with the information of the device explantation report which mentions a wire being exposed before explantation.However the patient was reportedly a good performer at the beginning, so it seems unlikely that the detected damage occurred during implantation.Device investigation additionally showed damage at the header feed throughs.This is likely related to explantation surgery, as telemetry history whilst implanted shows a device working within specification.The device was explanted due to non-auditory sensation and pain at the implant side, however no damage could be identified which could explant for the reported symptoms.This is a final report.

Event Description

It was reported that the patient was a good performer in the beginning, but after a while performance was fluctuating.After many fitting attempts and medical investigations nothing was found or improved.The clinical team advised the parents to replace the implant, but they refused and asked to implant the second ear.

• 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: 4791474
• MDR Text Key: 5799824
• Report Number: 9710014-2015-00353
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• 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: 07/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2015
• 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: 11 YR