BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6956438 · Received October 17, 2017

    Report

    Report Number
    3004209178-2017-22000
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Report Date
    October 17, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING RIGHT. THE PATIENT STATED THAT THEY HAD THREE LEAD WIRES GOING FROM THE IMPLANT TO THEIR SPINE AND THAT THERE WERE TWELVE ELECTRODES ON EACH ONE. THE PATIENT REPORTED THAT ¿IT¿ WAS ONLY WORKING ON THEIR LEG AND NOT ON THEIR HIP OR LOWER BACK, WHICH IS WHERE IT WAS WORKING BEFORE. THE PATIENT MENTIONED THAT THEY DIDN¿T NOTICE THE ISSUE UNTIL THEY WERE TRYING TO WORK WITH THE INS AND INCREASE SETTINGS FOR THOSE THREE AREAS. THE PATIENT STATED THAT THEY THOUGHT THEIR INS JUST NEEDED ADJUSTING. AN APPOINTMENT WAS SCHEDULED WITH THEIR HEALTHCARE PROVIDER (HCP) ON (B)(6) 2017 AND THE PATIENT REQUESTED THAT A MANUFACTURER REPRESENTATIVE BE PRESENT AS WELL. IT WAS NOTED THAT THE ISSUE STARTED ABOUT SIX WEEKS PRIOR TO THE DATE OF THIS REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. INDICATION FOR USE IS SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735139 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1