MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1000 MED-EL CONCERT

Device Problems Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Hearing Impairment (1881)

Event Type  Injury  

Event Description

The bilaterally implanted pt is reporting that the right side of his head is "too loud" though in situ measurements do not show any anomalies.There was a report that the child fell but it is not clear if the implant was effected.Remapping was attempted with minimal charge but the pt still claimed it was too loud.An integrity test carried out on (b)(6) 2015, led to the consideration of re-implantation.This is due to the consistent negative behavioural responses from the pt.Th e contra-lateral side has no issues.

Manufacturer Narrative

(b)(4).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

(b)(4).Based on measurements performed on the device whilst it was implanted and during explant investigation, it must be assumed that the explantation was not due to a technical problem.The patients perception was unsatisfactory, however, no technical problem could be detected.This is a final report.

Event Description

The bilaterally implanted patient is reporting that the right side of his head is "too loud".The patient was explanted on (b)(6) 2015.

• Brand Name: MED-EL MAESTRO 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: 4662158
• MDR Text Key: 20750524
• Report Number: 9710014-2015-00251
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737083632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• 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 Age: 5 YR