BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7046370 · Received November 20, 2017

    Report

    Report Number
    3004209178-2017-24094
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 2, 2017
    Report Date
    November 29, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REPRESENTATIVE (REP) REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS CURRENTLY TRYING OUT DIFFERENT PROGRAMS AND GROUPS INDIVIDUALLY. THE REP STATED THE PATIENT WAS KEEPING A JOURNAL OF THE SYMPTOMS THAT WERE OCCURRING. THE REP STATED THAT THEY WERE SUPPOSED TO BE IN TOUCH THIS WEEK TO SCHEDULE A FOLLOW-UP. THEY REPORTED THAT THE PHYSICIAN¿S OFFICE WAS ALSO WORKING TO SCHEDULE AN MRI. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A REPRESENTATIVE (REP) AND A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE THERAPY WAS TURNING ON AND OFF BY ITSELF. THE PATIENT REPORTED THEY WOULD FEEL THE STIMULATION GOING FROM 0 TO 10 VOLTS WHEN THEY WOULD TURN IT BACK ON. THEY NOTED THAT THEY CONFIRMED USING THE PATIENT PROGRAMMER (PP) TO CHECK THE INS ON/OFF STATUS. THE PATIENT REPORTED THAT THEY WOULD TURN THE INS COMPLETELY OFF, THEY WOULD MOVE, AND THE STIMULATION WOULD COME BACK ON. THE PATIENT NOTED THEY WOULD NEED TO USE THE CONTROLLER TO TURN THE STIMULATION BACK OFF. THEY STATED THAT THE PP WOULD SHOW THE INS WAS ON. IT WAS NOTED THE ISSUE HAD BEEN OCCURRING DAILY. THE PATIENT STATED THEY TRIED USING GROUP B AND THE INS SHUT OFF ON THEM THREE TIMES THIS MORNING. THE PATIENT REPORTED THE ISSUE HAD BEEN OCCURRING SINCE THEY FELL GETTING OUT OF A TRUCK AND HIT THE INS DIRECTLY. THE REP PERFORMED AN IMPEDANCE TEST WITH THE AVERAGE IMPEDANCE RANGING FROM 800-1489 OHMS. THE REP STATED THAT CONTACTS 11 AND 13 HAD IMPEDANCES IN THE RANGE OF 1200-1490 OHMS. THE PATIENT¿S GROUP A WAS PROGRAMMED AS: ¿A1: 5-6-7+, A2: 12-13-14+.¿ GROUP B WAS PROGRAMMED AS: ¿B1: 0-1-2+, B2: 11-12-13+.¿ THE PATIENT MENTIONED THAT THEY HAD LOST 200 POUNDS FOLLOWING IMPLANTATION DUE TO HAVING SURGERY FOR GASTRIC SLEEVE SHORTLY AFTER GETTING THE INS. THE PATIENT¿S CURRENT WEIGHT WAS LISTED AS (B)(6) POUNDS. NO FURTHER COMPLICATIONS WERE REPORTED. FOLLOW-UP WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823967 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR