BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3857099 · Received June 9, 2014

    Report

    Report Number
    3004209178-2014-10350
    Event Type
    Injury
    Date Received
    June 9, 2014
    Report Date
    May 19, 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 PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# V233248, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER LEAD REPLACED IN 2009 BECAUSE SHE HAD A LEAD ELECTRODE BREAK EVERY 6 MONTHS AND WAS ¿DOWN TO JUST A FEW LEAD CONTACTS.¿ IT WAS STATED THAT THE PATIENT HAD BEEN ¿TOSSED¿ WHILE BEING ON A TREADMILL, WHICH CAUSED HER LEAD TO DISCONNECT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR AND MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT OF (B)(6) 2014 WAS NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333739 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 00067 YR Required Intervention