BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3870725 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11524
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATION WASN¿T WORKING THE WAY IT USED TO EVER SINCE HER ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) WENT OFF/SHOCKED HER 1.5 MONTHS AGO. IT WAS REPORTEDLY NOT ¿VIBRATING¿ THE WAY IT USED TO (IT WAS CLARIFIED VIBRATING WAS REFERRING TO STIMULATION). IT WAS NOTED THE PATIENT WAS NOT FEELING STIMULATION IN THE SAME WAY AS SHE USED TO. THE PATIENT REPORTEDLY HAD HER STIMULATION ADJUSTED LAST MONTH. IT WAS NOTED THAT STIM WORKED FOR A COUPLE OF DAYS AND THEN IT STOPPED AGAIN AND THE PATIENT WASN¿T FEELING STIM ANY LONGER. THE PATIENT WAS FEELING A LITTLE STIM/TINGLING TODAY. THE MANUFACTURER REPRESENTATIVE (REP) INCREASED THE VOLTAGE AND THE PATIENT FELT STIM LIKE IT USED TO FEEL. THE PATIENT REPORTEDLY USED HER PATIENT PROGRAMMER (PP) TO ADJUST STIM. IMPEDANCES WERE WITHIN NORMAL RANGE THE DAY OF THE CURRENT REPORT. THE REP WAS GOING TO EDUCATE THE PATIENT AROUND CHANGING THE STIM LEVEL AND MAKE SURE THE PATIENT HAD A GOOD UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347980 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR