BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4093678 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17131
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 093-33, LOT# V742230, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHAT CAUSE THE LEAD TO BREAK WAS THAT THE BATTERY EXCHANGE WAS SCHEDULED AND IN SURGERY THEY GOT HIGH IMPEDANCES SO THEY SWITCHED THE LEAD. ALL PARTS OF THE LEAD WERE EXPLANTED AND THE EXPLANTED LEAD WOULD NOT BE REPLACED. THE LOCATION OF THE LEAD ISSUE WAS UNKNOWN. THE INVENTION TAKEN TO RESOLVE THE EVENT WAS THAT THEY PUT IN A NEW LEAD. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PATIENT¿S OLD IMPLANTABLE NEUROSTIMULATOR (INS) ONLY SHOCKED THEM ONCE IN (B)(6) 2013. IT WAS SO SEVERE THAT THE PATIENT HAD TO TURN THEIR THERAPY OFF. THE PATIENT ENDED UP CHANGING PROGRAMS AND HAD NO OTHER SHOCKING ISSUES. IN (B)(6) 2014 THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REALIZED THE PATIENT HAD A BROKEN LEAD WHEN THE MANUFACTURER REPRESENTATIVE INTERROGATED THE INS. ABOUT 6 MONTHS PRIOR TO THE PATIENT¿S REPLACEMENT THEY NOTICED A LOSS OF THERAPEUTIC EFFECT AROUND (B)(6) 2014. IN (B)(6) 2014 A NURSE REPROGRAMMED THE LEAD POSITIVE TO NEGATIVE WITH NO IMPROVEMENT AND IN (B)(6) 2014 THE LEAD WAS FOUND TO BE BROKEN. THE MANUFACTURER REPRESENTATIVE WAS MADE AWARE AND WAS PRESENT IN JULY WHEN THE LEAD WAS DISCOVERED BROKEN. TEN DAYS LATER IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE DID NOT KNOW ABOUT THE LEAD BEING BROKEN IN (B)(6) 2014. THE MANUFACTURER REPRESENTATIVE DID NOT BELIEVE THE MET WITH THE PATIENT BEFORE THE SYSTEM WAS REPLACED AND THEY HAD NO PRIOR KNOWLEDGE OF A LEAD BREAK. THE NURSES IN THE HCP'S OFFICE DID THE PROGRAMMING, SO THEY ASSUMED THE PATIENT MAY HAVE BEEN CONFUSED IF THERE WAS A MANUFACTURER REPRESENTATIVE OR A NURSE WITH THE OFFICE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573479 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention