BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3404578 · Received October 10, 2013

    Report

    Report Number
    3004209178-2013-18852
    Event Type
    Injury
    Date Received
    October 10, 2013
    Report Date
    September 20, 2013
    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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 377660, LOT# V021451, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377660, LOT# V021451, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708120, SERIAL# (B)(6), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT WAS AT THE EMERGENCY ROOM (ER) AT THE TIME OF THE REPORT FOR THE SHOCKING SENSATION WHICH ¿WAS RADIATING THROUGH HER ENTIRE BODY.¿ IT WAS FURTHER NOTED THAT THIS HAD BEEN OCCURRING FOR ABOUT 1.5 HOURS. IT WAS NOTED THAT THE PATIENT WAS LYING IN BED AND WATCHING TELEVISION WHEN THE SHOCKING OCCURRED. NO PATIENT FALLS OR TRAUMA WAS REPORTED. IT WAS FURTHER NOTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE PATIENT¿S INS PROGRAM WAS TURNED TO 0 VOLTS FOR ABOUT AN HOUR AND THE PATIENT NOTED THAT THE SHOCKING WAS MORE INTENSE WHEN THE STIMULATION WAS TURNED ON. IT WAS NOTED THAT THE SHOCKING WAS PAINFUL TO THE PATIENT. IT WAS FURTHER NOTED THAT THE PATIENT ¿SAW SMOKE COMING OUT OF HER MOUTH EARLIER.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ABOUT A YEAR AGO IN (B)(6) THE PATIENT'S LEADS WERE SHOCKING HER AND HER TWO LEADS WERE NOT WORKING. IT WAS REPORTED THAT THE PATIENT'S SYSTEM HAD BEEN REPLACED AND TODAY SHE REQUESTED COMPATIBILITY GUIDELINES FOR EMG AND NERVE CONDUCTION BECAUSE SHE WANTED TO MAKE SURE NOTHING HAPPENED TO HER SYSTEM. IT WAS NOTED THAT THE REPLACEMENT SURGERY 'WAS NOT EASY TO GET OVER.' IT WAS NOTED THAT THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520022 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention