BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8653521 · Received May 30, 2019

    Report

    Report Number
    3004209178-2019-10510
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109506
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    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 WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. THE PATIENT REPORTED THAT HE THOUGHT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS LEAKING BECAUSE HE HAD SEVERE BURNING ABOVE AND BELOW THE INS SITE. THE BURNING WAS NOTED TO BE ¿SO BAD¿ AND WAS LIKE BATTERY ACID. THE BURNING SENSATION AND IRRITATION WERE A REALLY SHARP PAIN THAT WOKE THE PATIENT UP IN THE MIDDLE OF THE NIGHT. WHEN THE PATIENT SHIFTS AT NIGHT, THE INS MOVES DOWN, IT WAKES HIM UP AND HE "WAS ON THE MOON". THE PATIENT THEN NOTED THAT IT WOULD TAKE 15 MINUTES FOR THE BURNING TO REDUCE, BUT IF HE MOVED TO ANOTHER POSITION, THE BURNING SENSATION WOULD RETURN; IT WAS LIKE ¿SALT ON AN OPEN WOUND¿. THESE ISSUES WERE DISCOVERED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE BURNING PAIN HAD DISSIPATED, BUT THE TISSUE WAS SOFT WHERE THE INS WAS. DUE TO THESE ISSUES, THE PATIENT NOTED THAT HE COULD NOT DRIVE, HE WAS LIMITED WITH HIS MOBILITY AND WAS VERY DISABLED. IN THE END, THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH A HEALTHCARE PROFESSIONAL (HCP) TO ADDRESS THE ISSUES. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447123 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712 00643169109506

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR