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

Model Number C40+

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Shock (2072)

Event Date 04/26/2013

Event Type  Other  

Event Description

It was reported that the patient was experiencing shocking sensation from the device both w/and w/o the processor in use.The patient was explanted of the device on (b)(6) 2015.

Manufacturer Narrative

Udi not available.The device has been explanted and has been returned to mfr for evaluation.When available, a device analysis will be submitted as a follow-up report.

Manufacturer Narrative

(b)(4).Device investigations did not reveal any device defect which is expected to have been present whilst implanted or would explain for the problems reported.The reported symptoms are present with and without the processor.The device worked within specification during investigation and whilst implanted.Therefore it is assumed, that the reported problems are due to device unrelated reasons.A root cause for the reported problem remains unknown.This is a final report.

Event Description

It was reported that the patient was experiencing shocking sensation from the device both with and without the processor in use.The patient was explanted of the device 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: 4963843
• MDR Text Key: 20718894
• Report Number: 9710014-2015-00544
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C40+
• Other Device ID Number: UDI NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• 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: 12 YR