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

Model Number	PULSAR
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Since (b)(6) 2024, the user reports sudden fluctuations in hearing (on/off/silent), especially in the evening.The user also experiences fluctuations in hearing when chewing and touching the internal device.There is also pain when touching the internal device.There has been no accident/trauma.External parts have been checked and are working properly.Re-implantation is being considered but no date has been set.
Additional Manufacturer Narrative
Conclusion: 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 the recipient was explanted because fluctuating hearing performance and discomfort was felt, which was likely caused by the reference electrode being influenced by bone growth around it.This is a final report.
Event or Problem Description
Since (b)(6) 2024, the user reports sudden fluctuations in hearing (on/off/silent), especially in the evening.There has been no accident/trauma.External parts have been checked and are working properly.The user has been re-implanted.

• Brand Name: PULSAR
• Common Device Name: 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: 21250749
• Report Number: 9710014-2025-00078
• Device Sequence Number: 13040845
• Product Code: MCM
• UDI-Device Identifier: 09008737093952
• UDI-Public: (01)09008737093952
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/01/2013
• Device Model Number: PULSAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female