BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4222714 · Received November 4, 2014

    Report

    Report Number
    3004209178-2014-20885
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 9, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V598061, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BACK PAIN. IT WAS NOTED THAT THE OUTCOME WAS ONGOING. IT WAS NOTED THAT INTERVENTIONS INCLUDED REPROGRAMMING. IT WAS NOTED THAT PROGRAM 3 PULSE WIDTH WAS CHANGED FROM 210 TO 180 AND THE AMPLITUDE WAS CHANGED FROM 1.1 TO 1.0 ON (B)(6) 2014. IT WAS NOTED THAT THERE WAS AN UNDESIRABLE CHANGE IN STIMULATION. IT WAS NOTED THAT THE PATIENT WAS COMPLAINING OF INTERMITTENT LOWER BACK PAIN AND SCIATIC PAIN RADIATING TO THE RIGHT THIGH. IT WAS NOTED THAT THIS WAS AGGRAVATED BY WALKING, STANDING, AND NORMAL DAILY ACTIVITIES. IT WAS NOTED THAT THE PATIENT ALSO HAD A RECENT INTENTIONAL WEIGHT LOSS OF 20 POUNDS AND MAY BE A CONTRIBUTING FACTOR. IT WAS NOTED THAT THE PATIENT DENIED FALLS OR TRAUMA. ADDITIONAL INFORMATION REPORTED THE PULSE WIDTH WAS CHANGED TO 210, AMPLITUDE WAS 1.35 AND THE RATE WAS 14 WITH LEADS 3 POSITIVE 2 NEGATIVE CYCLING 16 SECONDS ON 8 SECONDS OFF. THE PATIENT¿S ¿POKING¿ FEELING HAD IMPROVED. FREQUENCY HAD INCREASED AND THE PATIENT WAS SCHEDULED FOR ANOTHER REPROGRAMMING. THE EVENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. ADDITIONAL INFORMATION REPORTED THE PATIENT¿S PAIN CONTINUED DOWN THEIR LEG LIKE ¿ELECTRICAL SHOCK OR JOLT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708315 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR