BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3953484 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13434
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    May 15, 2014
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN RELOCATED BECAUSE IT WAS NOT IMPLANTED DEEP ENOUGH. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION DID OCCUR ON (B)(6) AND THE BATTERY WAS MOVED. IT WAS STATED THAT THE PATIENT SEEMED TO BE DOING BETTER. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE WOULD UPDATE UPON RECEIPT OF ADDITIONAL INFORMATION ABOUT THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE FOUND OUT ABOUT THE SURGERY THE DAY BEFORE IT HAPPENED. IT WAS STATED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE ABOUT ¿ANY FOLLOW UP OR ANYTHING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430247 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention