MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; NONE

Device Problem Device Inoperable (1663)

Patient Problems Bruise/Contusion (1754); Fall (1848); Hearing Loss (1882)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported tha the pt lost access to sound with the cochlear implant system afer a fall.A bruise was visible on the pt's pinna on the implant side.No swelling was noted.

Manufacturer Narrative

(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for eval.When available, a device failure analysis will be submitted as a f/u report.

Manufacturer Narrative

(b)(4).Conclusion: the investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the patient report and the reported accident appear to match well with this finding.This is a final report.

Event Description

It was reported that the patient lost access to sound with the cochlear implant system after a fail.A bruise was visible on the patient's pinna on the implant side.No swelling was noted.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: NONE
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6646070556
• MDR Report Key: 4788252
• MDR Text Key: 5879413
• Report Number: 9710014-2015-00343
• 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: Audiologist
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 5 YR