BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3955214 · Received July 24, 2014

    Report

    Report Number
    6000153-2014-00137
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 355018, LOT # W60128, PRODUCT TYPE ACCESSORY; PRODUCT ID 355018, LOT # W60128, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_INTERSTIM_INS, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_STYLET_ACC, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_INTERSTIM_INS, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_STYLET_ACC, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE TINED LEAD ((B)(4)) FOUND THAT DISTAL END OF THE LEAD WAS STRETCHED. ANALYSIS OF THE LEAD INTRODUCER ((B)(4)) FOUND THAT THE INTRODUCER SHEATH WAS DAMAGED. ANALYSIS OF THE STYLET FOUND THAT THE STYLET WIRE WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DUE TO PATIENT ANATOMY THE FORAMEN SEEMED VERY TIGHT PER THE HEALTH CARE PROVIDER (HCP) AND THE LEAD SEEMED TO BE STUCK IN THE INTRODUCER CAUSING WHAT LOOKED LIKE A KINK IN THE LEAD. THE HCP REQUESTED TO USE A NEW LEAD AND THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS THAT THE DEVICE WAS NOT IMPLANTED. IT WAS STATED THAT THE LEAD INTRODUCER SEEMED TO NOT PROGRESS THROUGH THE PATIENT¿S LEFT SIDE FORAMEN SMOOTHLY THUS CAUSING THE DISTAL TIP TO BE DAMAGED. THE HCP THOUGHT IT WAS THE PATIENT¿S ANATOMY AND NOT THE PRODUCT. IT WAS REPORTED THAT THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS THAT A DIFFERENT PRODUCT WAS USED. IT WAS REPORTED THAT DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED AS IT WAS NOT REQUIRED. IT WAS NOTED THAT IT WAS UNKNOWN IF THE PRODUCT ISSUE WAS RESOLVED AND THE CAUSE OF THE ISSUE WAS DETERMINED TO BE THE PATIENT¿S ANATOMY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT STATUS WAS ALIVE WITH NO INJURY. IT WAS REPORTED THAT THE LEAD AND LEAD INTRODUCER WOULD BE RETURNED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND THE DEVICE HAD BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434928 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3889-28 VA0JQYB

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR