MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT

Model Number MI1250 SYNCHRONY 2

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Seroma (2069)

Event Date 08/21/2023

Event Type  malfunction  

Event Description

The user has no more hearing sensation with the device.The user was hearing and progressing well, but the implant shifted significantly in (b)(6) 2023.Some time after surgery and before the activation, fluid pooled in the receiver stimulator/magnet area.A revision surgery was performed on (b)(6) 2023.During the revision, an extra gel packing to keep the implant in place was placed.The gel packs are taking a while to dissolve, so the retention of rondo 3 has been problematic.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Manufacturer Narrative

Conlclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field recipient suffered from a seroma at the implant site which led to a shift of the implant from its initial position.A revision surgery was performed, however, afterwards the user could not hear with the device anymore.Due to the lack of benefit the device was eventually explanted.As per device explantation report form the electrode was found completely outside of cochlea during explantation surgery.This is a final report.

Event Description

The user was hearing and progressing well, but the implant shifted significantly in (b)(6)2023.Some time after surgery and before the activation, fluid pooled in the receiver stimulator/magnet area.The cause of the seroma (excess fluid after the surgery) is unknown, but it is likely the cause of the implant shift.No trauma has been reported.A revision surgery was performed on (b)(6)2023.During the revision, an extra gel packing to keep the implant in place was placed.The revision report also mentions a "horizontal mattress" over the ci.The gel packs are taking a while to dissolve, so the retention of rondo 3 has been problematic.Coupling with sonnet 2 without pressing on the magnet is about 40%.If the user presses down on the magnet, it can go up to 90% but he reports no sound.Both rondo 3 and sonnet 2 were fit with a 5s magnet now.The recipient was seen again on (b)(6)2023.In situ measurements show a gpi (ground path impedance) of 0.2 kohm and low voltage gradient.With a flat map of 60 qu the user still has no hearing perception and also no facial nerve stimulation.The clinic decided to proceed with surgery but at this time no imaging will be done to check position of the array.The user has been re-implanted.As per explant report form, all channels were extra-cochlear at explantation.

• Brand Name: SYNCHRONY
• 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: 17610765
• MDR Text Key: 321817714
• Report Number: 9710014-2023-00744
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395445
• UDI-Public: (01)09008737395445
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• 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: 35 YR
• Patient Sex: Male