BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3820674 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09260
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    October 7, 2013
    Report Date
    May 1, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S LEAD WIRES WERE REPLACED DUE TO STIMULATION UNDER THE PATIENT¿S BREASTS INSTEAD OF BACK. IT WAS NOTED, THE PATIENT HAD SOME RELIEF AFTER THE REPLACEMENT. IT WAS REPORTED, THE PATIENT GOT LESS THAN FIFTY PERCENT PAIN RELIEF. IT WAS NOTED THERAPY SOMETIMES WORKED AND SOMETIMES DID NOT. IT WAS REPORTED, THE PATIENT USED A CANE TO WALK. IT WAS NOTED, THE PATIENT HAD BEEN REPROGRAMMED MULTIPLE TIMES. IT WAS REPORTED, THE PATIENT DID NOT WANT TO INCREASE STIMULATION DUE TO FEAR OF STIMULATION BEING PAINFUL AND UNCOMFORTABLE AND GETTING SHOCKED. IT WAS NOTED, THE PATIENT HAD BEEN REPROGRAMMED BEFORE AND GOT A BIG SHOCK WHEN THEY LAID DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300121 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention