BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2241040 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06497
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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

    IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE LEAD INTO THE NEUROSTIMULATOR. INTRA-OPERATIVE IMPEDANCES WERE MEASURED AND THE LEAD WAS NOT PLACED IN THE NEUROSTIMULATOR ALL THE WAY. THE PHYSICIAN UNSCREWED THE SCREW AND PUSHED THE LEAD FURTHER INTO THE NEUROSTIMULATOR, BUT COULD NOT GET THE SCREW TO RE-TIGHTEN. A DIFFERENT NEUROSTIMULATOR WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PT HAD NO COMPLICATIONS AND THE DEVICE WAS FUNCTIONING PROPERLY.

    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 59 YR EXPLANTED:| LEAD: MODEL 3093, LOT# V593241| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,| IMPLANTED:| EXPLANTED:| LOT# NJY160589H| PROGRAMMER: MODEL 3037, LOT# NJD119192N| IMPLANTED: