BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 12305372 · Received August 10, 2021

    Report

    Report Number
    2182207-2021-01388
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 10, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    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 MDT REP SUBMITTED THE IPG SN (B)(4) AS IMPLANTED FOR THIS PATIENT AND AN IDC WAS SENT. MDT REP CONFIRMS THE CORRECT SN FOR PATIENT¿ IS (B)(4). CORRECTED PATIENT'S RECORD AND SENT NEW IDC. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201771 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR