BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR

    MDR report key: 19769532 · Received July 18, 2024

    Report

    Report Number
    9710014-2024-00637
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 16, 2024
    Report Date
    October 2, 2024
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A FALL, HITTING HIS IMPLANT.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A FALL, HITTING HIS IMPLANT. THE USER HAS BEEN RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142989 PULSAR COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Required Intervention