BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6911702 · Received October 3, 2017

    Report

    Report Number
    3004209178-2017-20534
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 1, 2017
    Report Date
    October 3, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING POOR COMMUNICATION. THE CALLER REPORTED THAT THE PATIENT¿S INS ¿WENT TO SLEEP¿ AND NEEDED TO BE WOKEN UP. THEY STATED THAT THE PATIENT WAS UNABLE TO CHARGE THE INS. THE CALLER REPORTED THAT THE REASON FOR NOT CHARGING WAS DUE TO NON-COMPLIANCE. THEY STATED THAT THE PATIENT HAD TO MAKE A TRIP AND FORGOT THEIR INS RECHARGER (INSR). THE CALLER WAS REDIRECTED TO FOLLOW-UP WITH A HEALTHCARE PROFESSIONAL (HCP). THE CALLER STATED THAT THE PATIENT WAS IN SO MUCH PAIN. THEY REPORTED THAT THEY ¿DNK¿ IF THEY COULD GET THEM OFF THE COUCH. THEY NOTED THE PATIENT HAD PAIN ON FRIDAY, SATURDAY, SUNDAY, AND TODAY. NO FURTHER COMPLICATIONS WERE REPORTED. FOLLOW-UP WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692296 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR