BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4132820 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18090
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 9, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V157497, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. AT TIMES THE STIMULATION WOULD ¿SHOOT UP REAL FAST¿ AND THE PATIENT WAS NOT STANDING WHEN THIS WOULD HAPPEN. NO PATIENT FALLS OR TRAUMAS WERE REPORTED. THE PATIENT HAD TO RECHARGE EVERY DAY WHEN BEFORE SHE ONLY HAD TO RECHARGE EVERY 3 DAYS. IT USED TO TAKE HER 3-4 HOURS TO CHARGE, BUT NOW IT TOOK UP TO 9 HOURS. THE PATIENT ALWAYS HAD FULL COUPLING WHEN LYING DOWN, OTHERWISE SHE WOULD LOSE SOME OF THE BOXES. A THERMOMETER PICTURE WAS ALSO SEEN ON THE RECHARGER (INSR) TWICE AND IT WAS UNKNOWN IF THERE WAS A CODE ASSOCIATED WITH IT. IT WAS NOTED TO BE HOT IN THE PATIENT¿S HOUSE. THE ISSUES STARTED 2 WEEKS AGO. IT WAS NOTED THAT THE IPG WAS INVOLVED IN THE EVENT AND THAT TROUBLESHOOTING AND ACTIONS/INTERVENTIONS WERE PENDING. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FOLLOW-UP THAT WAS CONDUCTED REPORTED THE PATIENT WAS NOT RECOVERED AND SYMPTOMS WERE REPORTEDLY ONGOING. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612430 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR