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

Model Number SONATA

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the patient perforated his tympanic membrane and inadvertently damaged the device by the introduction of a metallic object into his ear canal.

Manufacturer Narrative

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: according to the information received, the patient had an itch in the ear and used a metal clip/hook in the external auditory ear canal to stop the itching.While doing it the patient inadvertently perforated the tympanic membrane and pulled the electrode.The concerned device was explanted.Device investigation showed a damage to the active electrode, which might be related to the dislocation of the electrode lead and is not supposed to be present before explantation.The patient had good access to sound before the incident.The investigation results appear to match the problems mentioned in the patient report.This is a final report.

Event Description

The patient had an itch in the ear and used a metal clip or hook to itch it.The patient then perforated the tympanic membrane and extruded the electrode.The patient had good access to sound before the incident.The patient has been re-implanted.

• 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: 4272156
• MDR Text Key: 5029356
• Report Number: 9710014-2014-00603
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• 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: 57 YR