BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5064532 · Received September 9, 2015

    Report

    Report Number
    3004209178-2015-17561
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 13, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888-56, LOT # V067340, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V009655, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V067340, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V020899, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-56, LOT # V067340, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V009655, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-56, LOT # V067340, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V020899, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4). LEAD FRAGMENT LEFT IN PATIENT UNINTENTIONALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) EXPLANTED THE ENTIRE SYSTEM TODAY AND THE DISTAL CONTACT OF THE LEAD BROKE OFF INTO THE BODY DURING EXPLANTATION. X-RAYS WERE UTILIZED DURING THE EXPLANT. THE DISTAL SINGLE CONTACT OF A LEAD REMAINS IN PLACE IN THE SUBCUTANEOUS TISSUE AREA. THE REP STATED THAT THE HCP WAS INQUIRING IF THIS WOULD EFFECT PATIENT'S MRI STATUS AND IF IT WOULD CAUSE IMAGE DISTORTION. IT WAS REVIEWED THAT DECIDING TO KEEP THE CONTACT IN THE BODY WOULD BE A MEDICAL DECISION. IT WAS REVIEWED THAT METAL OBJECTS THAT ARE LEFT IN THE BODY DO HAVE THE POTENTIAL FOR IMAGE DISTORTION BUT IT WAS SPECULATION IF THE SMALL CONTACT WOULD EFFECT THIS. THE CAUSE OF THE BROKEN LEAD WAS UNKNOWN. THE REASON FOR EXPLANTING THE DEVICE WAS UNKNOWN. THE BROKEN LEAD IN THE PATIENT WAS STILL UNRESOLVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597614 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other