BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2504557 · Received March 26, 2012

    Report

    Report Number
    3004209178-2012-01860
    Event Type
    Injury
    Date Received
    March 26, 2012
    Report Date
    February 29, 2012
    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
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 377660, LOT #V021032, IMPLANTED: (B)(6) 2007. LEAD: MODEL 399960, LOT #V020223, IMPLANTED: (B)(6) 2007. RECHARGER: MODEL 37752, SERIAL #(B)(4). PROGRAMMER: MODEL 37743, SERIAL #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT COULD NOT FEEL THE STIMULATION UNLESS THE VOLTAGE WAS TURNED UP HIGH, AND AT THAT LEVEL THE STIMULATION WAS PAINFUL. IT WAS UNCLEAR HOW LONG THIS HAD BEEN OCCURRING. THE HEALTH CARE PROFESSIONAL (HCP) STATED, THE PATIENT HAD BEEN ADMITTED FOR BACK PAIN AND THE COMPLAINT THAT THE STIMULATOR WAS NOT WORKING. THE DEVICE POCKET APPEARED BLUISH/GREENISH IN COLOR, BUT IT WAS NOT BRUISED OR SWOLLEN. THE POCKET WAS TENDER THOUGH AND THE PATIENT COULD NOT LIE ON THAT SIDE. PER THE HCP, THE PATIENT DID NOT HAVE ANY FEVER OR SIGN OF INFECTION AT THE POCKET. THE PATIENT DID (B)(6) INFECTION, BUT IT WAS UNKNOWN IF THIS INFECTION WAS RELATED TO THE DEVICE. THE PATIENT HAD NOT SEEN HIS FOLLOW UP DOCTOR FOR HIS COMPLAINT ABOUT THE STIMULATION BUT HAD AN APPOINTMENT "SOME TIME" THAT WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Hospitalization