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

Model Number MI1200 SYNCHRONY PIN

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Electric Shock (2554)

Event Type  Injury  

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.

Event Description

In (b)(6) 2020 an implant exposure was seen from the skin behind the ear.Furthermore, the electrode had extruded into the external auditory canal.An infection was confirmed.Explantation is scheduled for the (b)(6) 2020.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechnical damages found during investigation are attributable to the removal surgery.This finding was expected because the device was explanted due to an implant exposure through the skin.Further the electrode extruded into the external ear canal.According to the information received, the recipient had a canal wall down mastoidectomy likely due to a chronic middle ear disease, including the reported cholesteatoma.The reported surgical approach is known to bear the risk of lead extrusion through the posterior ear canal.In addition, ongoing infection at the implant site has been observed and several auricular cultures were able to isolate different pathogens.Considering the proper sterilization of the device and the type of pathogens isolated, the reported infection and subsequent device exposure was likely due to colonization of the surgical site at the time of surgery.This is a final report.

Event Description

In (b)(6) 2020 an implant exposure was seen from the skin behind the ear by the incision site.According to the device explantation report form on the (b)(6) 2020 a cutaneous fistula developed in the posterior part of the auricle and was drained.The skin defect didn't improve with treatment and enlarged exposing the implant.Furthermore, the electrode had extruded into the external auditory canal.An infection was confirmed.Auricular cultures obtained in different time periods, isolated several bacteria, including corynebacterium, p.Aeruginosa and cns.The user was explanted on the (b)(6) 2021.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 11443208
• MDR Text Key: 238661833
• Report Number: 9710014-2021-00151
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR