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

Model Number	PULSAR
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/27/2025
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
According to the user's mother the user was standing in the kitchen when she passed out.As she fell, she hit her right side.The mother thinks she mostly hit her right shoulder, although her processor coil flew off and the audiostream cover broke.When reassembling the external devices, the user could no longer hear.The user's mother had tried a back up processor and the recipient could still not hear.After replacing parts on the sonnet processor, the user could no longer hear with the original processor either.Processor and dl coil lights were functioning normally on the sonnet.Mom had a speech processor test device (sptd) and the sptd indicated that both processors were functioning normally.It was suggested to user's mother to reach out to her clinic for a technical check of the internal device.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure due to the reported impact seems likely.However to determine an exact root cause device investigation would be necessary.Further technical checks are scheduled.
Event or Problem Description
According to the user's mother the user was standing in the kitchen when she passed out.As she fell, she hit her right side.The mother thinks she mostly hit her right shoulder, although her processor coil flew off and the audiostream cover broke.When reassembling the external devices, the user could no longer hear.The user's mother had tried a back up processor and the recipient could still not hear.After replacing parts on the sonnet processor, the user could no longer hear with the original processor either.Processor and dl coil lights were functioning normally on the sonnet.Mom had a speech processor test device (sptd) and the sptd indicated that both processors were functioning normally.
Event or Problem Description
According to the user's mother the user was standing in the kitchen when she passed out.As she fell, she hit her right side.The mother thinks she mostly hit her right shoulder, although her audio processor coil flew off.When reassembling the external devices, the user could no longer hear.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed mechanical damage to the stimulator housing and electronics that is typical for severe external impact to the housing.The problems described in the recipient report and the reported accident appears to match the damage found.This is a final report.

• 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: 21749784
• Report Number: 9710014-2025-00304
• Device Sequence Number: 10161585
• Product Code: MCM
• UDI-Device Identifier: 09008737335632
• UDI-Public: (01)09008737335632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2025

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 Model Number: PULSAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 03/28/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/09/2025; 11/13/2025
• 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: 22 YR
• Patient Sex: Female