BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4862457 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12045
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37651FA, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND BURNING IN THEIR LEGS. THE PATIENT DESCRIBED THE PAIN AS MOVING FROM THE INSIDE OUTWARD. THE PATIENT THOUGHT THAT THE PAIN MAY BE RELATED TO THE STIMULATOR BUT THE DOCTORS AT THE HOSPITAL DIDN¿T UNDERSTAND WHAT THE PATIENT WAS DESCRIBING. IT WAS NOTED, THE PATIENT HAD BEEN IMPLANTED SINCE 2009 BUT RECEIVED A RECENT BATTERY REPLACEMENT WHICH IS WHY THE PATIENT THOUGHT THE PAIN MAY BE RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) AND WANTED TO GET A MANUFACTURER¿S REPRESENTATIVE (REP) TO THE HOSPITAL TO CHECK THE DEVICE AND HAD CONTACTED THE REP. THE DAY OF THE REPORT. THE HEALTHCARE PROVIDER (HCP) DIDN¿T KNOW IF THE PATIENT HAD ATTEMPTED TO TURN STIMULATION OFF TO SEE IF THAT CHANGED THE PERCEPTION OF PAIN. THE PATIENT CALLED BACK AND STATED THAT SHE WAS IN THE HOSPITAL AND NO ONE COULD TELL HER WHAT WAS GOING ON. THE NEW DEVICE WAS IMPLANTED ON (B)(6) 2015 AND A WEEK AFTER SHE HAD BEEN SICK AND THOUGHT HER BODY WAS FIGHTING THE BATTERY. THE PATIENT STATED SHE HAD BIG LARGE HOT/BURN MARKS ON HER LEFT LEG/ANKLE. THE LINE WAS GOING UP HER LEG LIKE A BURN. IT WAS NOTED, SHE HAD AN INS PREVIOUSLY AND HAD NOT HAD ISSUES. THE PREVIOUS LEADS WERE KEPT BUT THE PATIENT THOUGHT MAYBE THE BATTERY WAS TOO STRONG COMPARED TO THE LAST INS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407487 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization