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

Model Number MI1000 MED-EL CONCERT PIN

Device Problems Device Operates Differently Than Expected (2913); Electrical Shorting (2926)

Patient Problems Idioventricular Rhythm (1923); Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

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.

Event Description

It was reported that in situ testing showed an increasing number of channels involved in short circuits through time.Latest in situ testing showed 6 electrode channels with status sc.An accident or trauma is not known.Re-implantation is being considered.

Manufacturer Narrative

Conclusion: during device investigation only one short circuit (between 9 and 12) out of reported three could be replicated.This is most likely due to the fact that the location of wires was shifted during the explantation, and for that reason not all short circuits could be detected.Possible causes to be considered for the observed short circuit include a technical defect of the active electrode as well as external mechanical influences.This is a final report.

Event Description

In situ testing showed an increasing number of channels involved in short circuits through time.Latest in situ testing showed 6 electrode channels involved in short circuits.An accident or trauma is not known.The patient has been re-implanted.

Manufacturer Narrative

Patient code and conclusion code were incorrect and has been amended.

Event Description

In situ testing showed an increasing number of channels involved in short circuits through time.Latest in situ testing showed 6 electrode channels involved in short circuits.An accident or trauma is not known.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 (Section G): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; fuerstenweg 77a; innsbruck, tirol ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 4991684
• MDR Text Key: 23856159
• Report Number: 9710014-2015-00581
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Other Device ID Number: (01) 09008737062675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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: 4 YR