BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3132937 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08269
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 3, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: RECHARGER: PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A-45, LOT# V085148, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2009, THE PATIENT¿S LEADS ¿SNAPPED AND BROKE AWAY FROM THE SPINE.¿ IT WAS NOTED THAT THERE WAS A ¿LUMP ON HIS SPINE THAT HAD NOT BEEN THERE BEFORE¿ AFTER THE LEADS WERE REPLACED. IT WAS NOTED THAT THIS LUMP WAS NOT PAINFUL OR SORE. IT WAS NOTED THAT THE LUMP WAS ¿3 INCHES LONG AND ABOUT A HALF AN INCH ABOVE THE SPINE ELONGATED.¿ IT WAS NOTED THAT THE ¿PHYSICIANS DID NOT KNOW WHAT IT WAS.¿

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE WAS NO DOCUMENTATION OF A ¿LUMP¿ ON THE PATIENT¿S SPINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S BACK WAS "GETTING WORSE." THE PATIENT REPORTED THAT "AT CERTAIN TIMES, MY POSITION, I DON'T FEEL IT AT ALL...AND THEN IF I CHANGE POSITION, IT CAN GET UP TO 3." THE PATIENT REPORTED THEY WERE UNABLE TO RECEIVE AN MRI TO DETERMINE WHAT THE "BUMP" WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235517 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 Required Intervention