BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2043562 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02323
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING AN IMPLANT PROCEDURE, THE PHYSICIAN COULD NOT TIGHTEN DOWN THE SET SCREW ONTO THE LEAD WHEN IT WAS INSERTED INTO THE NEUROSTIMULATOR. SPECIFICALLY, THE SCREW WOULD NOT CATCH AS IF THE DEVICE WAS "STRIPPED". A NEW NEUROSTIMULATOR WAS THEN USED IN ITS PLACE AND THE IMPLANT PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR PROGRAMMER: MODEL 3037, LOT# NJD124579N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V619241