BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3853720 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10253
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (NJY236355H) FOUND THAT THE INS SETSCREW WAS CROSS-THREADED. ANALYSIS OF THE TINED LEAD (VA0CVE7) FOUND NO ANOMALY. ANALYSIS OF THE WRENCH ACCESSORY FOUND NO ANOMALY. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA0CVE7, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0CVE7, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID NEU_WRENCH_ACC, SERIAL# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY COULD NOT GET THE LEAD TO STAY IN THE BATTERY. THERE WERE MULTIPLE IMPEDANCES AND THEY COULDN¿T GET IT TO WORK WITHOUT IMPEDANCES. IT WAS NOTED THAT THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT IMPLANTED. THE DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED WAS IMPEDANCE TESTING. IT WAS REPORTED THAT THE PRODUCT ISSUE WAS NOT RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE LEAD HAD HIGH IMPEDANCE GREATER THAN 4000 OHMS ON ELECTRODES 0 AND 1. IT WAS NOTED THAT A DIFFERENT LEAD WAS USED AS A RESULT OF THE EVENT. A NEW LEAD AND BATTERY WERE USED AND THE PATIENT STATUS WAS ALIVE WITH NO INJURY. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE LEAD AND INS WERE NEVER IMPLANTED AND WOULD BE RETURNED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING FINE AND THERAPY HAD BEEN EFFECTIVE. THE BATTERY AND LEAD HAD BEEN SENT IN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO PATIENT DEATH AND THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE AFTER THE DEVICE WAS REMOVED. IT WAS NOTED THAT THE HOSPITAL WAS LOOKING FOR REPLACEMENT PRODUCT AND THEY TRIED FOR OVER 30 MINUTES TO GET THE LEAD AND BATTERY TO OPERATE AND CONNECT AND COULD NOT MAKE IT HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333151 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR