BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3979534 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13942
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377760, LOT# V014129, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377760, LOT# V014129, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD TWO LEADS THAT DID NOT FUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REFERRED TO A PAIN CLINIC AND TOUCHED BASE WITH CLINIC ONE WEEK PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458237 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 00033 YR