BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3973701 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13840
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 8, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS PRODUCT ID 3093-28, LOT # V189561, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT ON (B)(6) 2014, HE ORDERED AN EXPLANT KIT FOR THIS PATIENT AS THE BATTERY WAS DOWN TO 3 MONTHS. IT WAS NOTED THAT THE IMPEDANCES ON THE LEAD WAS GREATER THAN 4000 OHMS ON ALL CONTACTS. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AT THE HEALTH CARE PROVIDER¿S OFFICE IN (B)(6) 2014 AND SAW THAT THE IMPEDANCES WERE HIGH. THE PATIENT WAS SCHEDULED FOR REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. SINCE THE PATIENT GOT THE DEVICE IN 2009 THEY HAD ONLY HAD SHORT PERIODS OF SUCCESS. THE PATIENT HAD HAD THERAPEUTIC EFFECT FOR A COUPLE OF DAYS IN A ROW WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WORKED PERFECT. IT WAS NOTED THAT THE PATIENT HAD BEEN IN TO HAVE THEIR STIMULATION ADJUSTED SEVERAL TIMES AND 1 SETTING THAT WORKED THE BEST CAUSED PAIN DOWN THEIR LEG. THE PATIENT DIDN¿T CARE IF THEY HAD PAIN DOWN THE LEG AND THEY USED A SETTING OF 3.0V OR LESS. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD ADJUSTED THE STIMULATION SEVERAL TIMES TO FIND A SETTING THAT WOULD WORK BEST AND THE PATIENT HAD TRIED THE 1 TO 4 SETTINGS. FOR THE PATIENT¿S PRIOR APPOINTMENTS THEIR HEALTH CARE PROVIDER (HCP) HAD NOT BEEN SUCCESSFUL AT CALLING IN A MANUFACTURER REPRESENTATIVE AND THEY WANTED TO LET THE MANUFACTURER KNOW THAT THEY HAD AN APPOINTMENT COMING UP IN 6 DAYS. A MANUFACTURER REPRESENTATIVE SPOKE WITH THE PATIENT AND WAS SCHEDULED TO MEET THEM AT THEIR APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS FIRST NOTIFIED OF THE EVENT ON (B)(6) 2014 WHEN THE PATIENT WAS SEEN IN THEIR HCP¿S OFFICE. DIAGNOSTICS WERE COMPLETED AND THEY SHOWED THAT THE LEADS WERE NOT FUNCTIONING AND THE CAUSE WAS UNKNOWN AT THIS TIME. IT WAS NOTED THAT THE BATTERY LIFE SHOWED ONLY 3 MONTHS REMAINING AND THE PATIENT¿S HCP HAD SCHEDULED A REPLACEMENT FOR (B)(6) 2014. CURRENTLY THE DEVICE WAS TURNED OFF AND THE MANUFACTURER REPRESENTATIVE DID NOT KNOW IF THE PATIENT WAS IN CONTINUOUS OR CYCLING MODE. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE WOULD ORDER A MAILER KIT AND SEND THE DEVICE BACK WHEN THE PROCEDURE WAS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449846 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention