BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 12908462 · Received December 1, 2021

    Report

    Report Number
    2182207-2021-02079
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Report Date
    December 1, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    UDI-DI
    00763000449711
    PMA / PMN Number
    P970004
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE MANUFACTURING REPRESENTATIVE (REP) (B)(4) WAS INCORRECTLY REGISTERED TO THIS PATIENT AND AN IDC WAS SENT. THE CORRECT SN FOR THIS PATIENT IS (B)(4). CORRECTED PATIENT'S RECORD AND SENT NEW IDC. NP PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809627 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 3058 00763000449711

    Patients

    Seq Age Sex Outcome Treatment
    1 Female