BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3910120 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12446
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37711, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37714, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 74002, LOT # N346974, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 74002, LOT # N202767, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ADAPTER; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT # LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # LA1828, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # L92553, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT # LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # LA1828, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # L92553, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION. (B)(4). THE EVENT WAS INITIALLY FILED UNDER THE ORIGINALLY IMPLANTED DEVICES. THIS EVENT CONTAINS A CONTINUATION OF THAT EVENT, WITH ISSUES ON A NEW DEVICE. FOR THE ORIGINALLY FILED EVENT, SEE REPORTS: 3004209178-2014-07347, 3004209178-2014-07347, 3004209178-2014-07347, 3004209178-2014-07347, 3004209178-2014-07347, 3004209178-2014-07349, 3004209178-2014-07349, 3004209178-2014-07349, 3004209178-2014-07349, AND 3004209178-2014-07349.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE LEAD REVISION HIGH IMPEDANCES WERE SEEN. IT WAS STATED THAT THE SAME LEADS WERE BEING USED, BUT AN EXTENSION WAS BEING CHANGED. IT WAS STATED THAT AFTER SETTING THE CORRECT LEAD CONFIGURATION, ALL IMPEDANCE ISSUES RESOLVED AND WERE WITHIN 800-1100OHMS. IT WAS STATED THAT ¿ON ONE SIDE OF THE EXTENSION IT LOOKED AS IF THE INSIDE METAL PIECE HAD TURNED ON ONE CONTACT.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE PROCEDURE THE PATIENT WAS NOT RECEIVING STIMULATION WHERE HE NEEDED IT. IT WAS NOTED THAT THE PATIENT WAS DOING GREAT AND WAS RECEIVING EFFECTIVE AND FULL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386418 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention