BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUNCTIONAL STIMULATION

    MDR report key: 3812407 · Received May 15, 2014

    Report

    Report Number
    3007566237-2014-01327
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A SHOCK AFTER THEY PASSED THROUGH A SUPERMARKET METAL DETECTOR. IT WAS NOTED THAT THE PATIENT WENT BACK TO THE HEALTH CARE PROFESSIONAL (HCP) BECAUSE THE THERAPY WAS NOT EFFECTIVE ANYMORE. IT WAS NOTED THAT IMPEDANCES OF THE SYSTEM WERE BAD ON THREE ELECTRODES. IT WAS NOTED THAT IT WAS DETERMINED THAT THE IMPEDANCE ISSUE WAS DUE TO THE LEAD. IT WAS NOTED THAT THE HCP DECIDED YESTERDAY TO CHANGE THE LEAD AND EXTENSION AND KEEP THE IMPLANTABLE NEUROSTIMULATOR (INS) AS IT LOOKED OK. IT WAS NOTED THAT DAMAGE WAS DETECTED CAPPING THE LEAD. IT WAS NOTED THAT AT THE END OF THE PROCEDURE THE IMPEDANCES OF THE IMPEDANCES OF THE SYSTEM WERE OK. IT WAS NOTED THAT TODAY AFTER PROGRAMMING THE IMPEDANCES WERE CHECKED AND THERE WERE 4 ELECTRODES WITH BAD IMPEDANCES. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AND THERE WERE NO FURTHER PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY BUT IMPEDANCE WAS HIGH ON "4 PLOTS". NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291643 FUNCTIONAL STIMULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention