BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3113852 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07709
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 25, 2013
    Report Date
    August 20, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3093-33, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND DAMAGED BALSEALS IN THE DISTAL END OF THE CONNECTOR BLOCK AND MARKINGS ON THE INSIDE OF THE CONNECTOR BLOCK. THE SETSCREW WAS BACKED OUT AS WELL.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED CONCLUSION CODE NO LONGER APPLIES TO THIS EVENT. ADDITIONAL REVIEW DETERMINED METHOD CODE NO LONGER APPLY. ADDITIONAL REVIEW DETERMINED RESULT CODE NO LONGER APPLIES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ¿SOME BLOOD¿ INSIDE THE HEADER BLOCK OF THE DEVICE. THE LEAD WAS UNABLE TO BE INSERTED AFTER WIPING IT ¿SEVERAL¿ TIMES BECAUSE THE BLOOD WAS AT THE END TIP OF THE DEVICE. LATER THAT DAY IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAD DIFFICULTY INSERTING THE LEAD INTO THE CONNECTOR BLOCK. WHEN THE LEAD WAS SUCCESSFULLY INSERTED THE IMPEDANCES WERE GREATER THAN 4,000 OHMS. A NEW DEVICE WAS OPENED AND THERE WERE NO ISSUES ENCOUNTERED DURING THE CONNECTION PROCESS. IMPEDANCES WERE ALSO NORMAL. FIVE DAYS LATER IT WAS REPORTED THAT GOOD IMPEDANCES WERE UNABLE TO BE OBTAINED DUE TO ¿RESISTANCE WITHIN THE DEVICE.¿ THERE WAS NO PATIENT INJURY AND SHE RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214611 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR