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

Device Problem Disconnection (1171)

Patient Problem Head Injury (1879)

Event Type  malfunction  

Event Description

It was reported that the fluctuations in situ testing results were observed.There was no report of any impact to the implant site.The patient showed significant improvement in the aided thresholds with the cochlear implant, however, the patient did not show any improvement in speech perception since implantation.As per additional information received, art responses were observed on all electrodes except for 8, 11 and 12.A ct scan indicated that 10 out of 12 electrodes are inside the cochlear.Impedances of intracochlear electrodes are ok.As per implant registration card, a full insertion was achieved at implantation.Reportedly, the clinic thinks that the poor performance could be due to late implantation.Information received on march 16, 2015, stated that the patient has visited the clinic with her mother complaining about disconnection of the signal received by the patient from time to time.Parents reported a trauma to the patient forehead.In situ measurements showed fluctuations on all channels except 5 and 11.Re-implantation is considered but no date has been scheduled yet.

Manufacturer Narrative

Based on received information, damage to the active electrode most likely caused by the reported trauma is to be assumed.Additionally, a partial electrode array migration into the middle ear, as confirmed by diagnostic imaging, might have been a contributory factor for the previously observed poor performance.However, to confirm a root cause, a device investigation is necessary.No date for revision surgery has been scheduled yet.Should additional relevant information be received, a follow up report will be sent.This report is otherwise an initial and final.

Manufacturer Narrative

Conclusion damage to the active electrode likely caused by minute device mobility was determined to have led to device failure over time.Additionally, the reported accident has most likely led to further damage to the active electrode, hence also a contributing factor to the device failure.The investigation results appear to match the problems mentioned in the patient report.This is a final report.

Event Description

Patient has been re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: MED-EL CONCERT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4688032
• MDR Text Key: 5670585
• Report Number: 9710014-2015-00269
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 04/02/2015

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2015
• 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: 8 YR