BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6698028 · Received July 10, 2017

    Report

    Report Number
    3004209178-2017-14501
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    March 19, 2017
    Report Date
    July 10, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3487A-56, LOT# VA005N5, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-45, LOT# VA05QGA, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# VA0553W, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V931748, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THEY WERE HAVING MOVEMENT IN THEIR WIRES, AS WELL AS THE DEVICE ITSELF THAT WAS IMPLANTED IN THEIR CHEST. IT WAS NOTED THAT THE ISSUE STARTED ABOUT THREE MONTHS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT STATED THAT THEY HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED ON (B)(6) 2016 AND THAT IT LOOKED LIKE IT WAS GOING TO ¿ERUPT OUT¿ AGAIN. THE PATIENT MENTIONED THAT THEIR HEALTHCARE PROVIDER (HCP) HAD CONCERNS ON THE ISSUE AS WELL. IT WAS REPORTED THAT THE WIRES POPPED OUT IN THE PATIENT¿S JAW AND THAT THEIR JAW WAS HURTING MORE. THE PATIENT THOUGHT THAT THE INS WAS DEAD OR NOT WORKING AND STATED THAT THEY COULDN¿T FEEL THE WIRE ANYMORE. THE PATIENT MENTIONED THAT THEY HAD A NERVE BLOCK DONE ON (B)(6) 2017 WHERE THEIR HCP GAVE THEM SHOTS ON THE INSIDE OF THEIR MOUTH, WHICH CAUSED SWELLING ALONG THE JAW LINE. AFTER FOUR DAYS, THE PATIENT¿S WIRE POPPED OUT OF THEIR JAW WHILE THEY WERE SLEEPING. THE PATIENT STATED THAT IT ¿LITERALLY WOKE THEM UP.¿ IT WAS NOTED THAT THE WIRE WAS FINE BEFORE THE NERVE BLOCK. THE PATIENT MENTIONED THAT THEY WOULD BE REACHING OUT TO A MANUFACTURER REPRESENTATIVE TO RESOLVE THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. INDICATIONS FOR USE ARE CERVICAL/NECK AND SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479325 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR