BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2878469 · Received December 18, 2012

    Report

    Report Number
    3004209178-2012-12003
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    November 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3487A-56, LOT# V012591,# IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3487A-56, LOT# V012591, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED LOSS OF THERAPY AND LEADS WERE SUSPECTED SO PATIENT'S HEALTHCARE PROVIDER (HCP) DECIDED ON LEAD REVISION. THE LEADS WERE EXPLANTED. BLOOD WAS NOTED IN EXTENSION AND CONNECTOR PORT LEADING TO ONE LEAD, ANOTHER LEAD HAD "UNKNOWN IMPEDANCE ISSUE," BUT IT WAS NOT CLEAR WHAT WAS MEANT BY THAT. LESS THAN 50% THERAPY RELIEF ON THE "LEFT SIDE IMPLANT" WAS STATED AS PATIENT SYMPTOMS/COMPLICATIONS. PATIENT STATUS AT TIME OF THIS REPORT WAS STATED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT.

    Devices

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