BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3200264 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11146
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    April 10, 2013
    Report Date
    June 10, 2013
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37742, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD ACUTE PAIN, AND STATED THAT HER LEGS HAD GOTTEN WORSE. THE PATIENT HAD ORTHOPEDIC SURGERY THE PRIOR (B)(6) AND HAD RODS AND SCREWS IMPLANTED INTO HER BACK. THE PATIENT REPORTED THAT THE PATIENT GOT A BLISTER ON HER HIP AFTER HAVING THE RECHARGER ON OVERNIGHT. THE PATIENT STATED IT HAD BURNED HER ¿BUTT.¿ THE PATIENT WAS UNSURE IF SHE WAS CHARGING OR IF SHE ONLY HAD IT ON. THE BLISTER HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300431 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 00060 YR