BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6589897 · Received May 24, 2017

    Report

    Report Number
    3004209178-2017-11011
    Event Type
    Injury
    Date Received
    May 24, 2017
    Date of Event
    December 21, 2016
    Report Date
    June 26, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V062112, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND THE OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V062112, IMPLANTED: (B)(6)2007, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS INDICATED THAT AN EXPLANT WAS PLANNED BUT THE ISSUE WAS UNKNOWN. IT WAS NOTED THAT IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2017-DEC-26. THE REP REPORTED THAT IT WAS UNKNOWN IF THERE WAS A DEVICE ISSUE, PATIENT/THERAPY ISSUE, OF PROCEDURE ISSUE. THE REP NOTED THAT IT WAS UNKNOWN WHAT TROUBLESHOOTING WAS PERFORMED AND THAT THE CAUSE OF THE SCHEDULED EXPLANT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND HCP VIA A REP. IT WAS REPORTED THAT BATTERY AND LEAD REMOVAL WERE DISCUSSED. THE PATIENT¿S HUSBAND REPORTED THAT THE DEVICE WAS PLACED IN 2007 AND A MONTH LATER THE PATIENT HAD A STROKE. THE BATTERY WAS INTERROGATED AND SHOWED THAT IT WAS A NON-FUNCTIONAL BATTERY. THE PATIENT¿S HUSBAND NOTED THAT THEY WANTED IT REMOVED SO THAT THE PATIENT COULD HAVE FUTURE MRI¿S. IT WAS INDICATED THAT AN EXPLANT W AS PLANNED. NO FURTHER COMPLICATIONS WERE REPORTED OR WERE EXPECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REP. IT WAS REPORTED THAT IT WAS NOT KNOWN WHAT ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE THE NON-FUNCTIONAL BATTERY AND THE CAUSE OF IT WAS NOT DETERMINED. THE CAUSE OF THE STROKE WAS UNKNOWN AND IT WAS UNKNOWN IF IT WAS RELATED TO THE DEVICE OR THERAPY. HOWEVER, BOTH ISSUES WERE RESOLVED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370057 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other