BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 4124830 · Received September 29, 2014

    Report

    Report Number
    3004209178-2014-17860
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Report Date
    September 5, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-33, LOT# V013723, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3587A, LOT# L84198, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A WEEK BEFORE THE CALL THE PATIENT HAD PNEUMONIA. IT WAS STATED THAT THE PATIENT HAD BEEN ACTING CONFUSED, BUT IT HAD TURNED OUT TO BE A URINARY TRACT INFECTION, (UTI). IT WAS STATED THAT A CT SCAN HAD BEEN DONE YESTERDAY ¿DUE TO POSSIBLE STROKE.¿ IT WAS STATED THAT THE PATIENT¿S BODY ¿WAS SHAKING ALL OVER¿ EVER SINCE. IT WAS STATED THAT THE PATIENT HAD BEEN TAKEN TO THE EMERGENCY ROOM AND THEN BACK TO THE NURSING HOME WHEN THE SHAKING WAS NOTED. IT WAS STATED THAT THE UTI HAD PUT THE PATIENT BACK IN THE HOSPITAL. THE CALLER STATED THAT THE PATIENT HAD NOT USED THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿IN YEARS¿ AND WANTED TO KNOW IF THE INS WAS STILL WORKING. IT WAS NOTED THAT THE CALLER WOULD GET NEW BATTERIES FOR THE CONTROLLER TO CHECK THE DEVICE. IT WAS NOTED THAT THE PATIENT WAS IN A NURSING HOME AND THE CALLER DIDN¿T BELIEVE THE PATIENT HAD USED THE INS IN 5 OR 6 YEARS. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO GET A MANAGING HEALTHCARE PROFESSIONAL (HCP) DUE TO HEALTH ISSUES. IT WAS FURTHER REPORTED THAT TH E CALLER HAD CHANGED THE PROGRAMMER BATTERIES AND TURNED THE INS BATTERY OFF. IT WAS REPORTED THAT THIS ACTION STOPPED THE SHAKING. IT WAS NOTED THAT THE CALLER ASKED IF KEEPING THE INS IN COULD HURT THE PATIENT. IT WAS FURTHER NOTED THAT THE CALLER REQUESTED A MANUFACTURER¿S REPRESENTATIVE TO CHECK THE BATTERY ON THE PATIENT¿S STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604904 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR