BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6841108 · Received September 4, 2017

    Report

    Report Number
    3004209178-2017-18673
    Event Type
    Malfunction
    Date Received
    September 4, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 4, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN AND LUMBAR RADICULOPATHY. THE PATIENT STATED THAT THEIR STIMULATION TURNED OFF ON THE DAY OF THE REPORT IN THE MORNING. THEY WENT TO USE THEIR PROGRAMMER AND GOT A POWER ON RESET (POR) WITH PHYSICIAN. THEY READ THROUGH THE MANUAL AND CLEARED THE POR. THEIR STIMULATION WAS NOW ON BUT THE PATIENT WAS UNSURE WHY THEY GOT THE SCREEN. THE CAUSE REMAINS UNKNOWN. THE PATIENT WOULD BE MEETING WITH A REP TOMORROW AT 10:45 TO EVALUATE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED FROM A REP ON (B)(6) 2017. THE PATIENT REPORTED GETTING A POR MESSAGE WHILE LYING IN BED YESTERDAY MORNING. SUPPOSEDLY, THE PATIENT CLEARED THE MESSAGE BUT WHEN THE REP INTERROGATED THE IMPLANT THEY SAW THE POR MESSAGE AND HAD TO CLEAR IT. THE PATIENT¿S THERAPY WAS BACK ON AND THE PATIENT REPORTED HAVING ADEQUATE THERAPY. THE PATIENT ALSO NOTED THAT THEY FELT STIMULATION WHILE IN THE POR CONDITION. THE POR WAS A 0X400 PARITY ERROR. IMPEDANCES WERE 800-1032 OHMS. TROUBLESHOOTING RESOLVED THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM A REP ON (B)(6) 2017. THE REP STATED THAT THE POR WAS A PARITY POR AND USUALLY DISPLAYS AFTER A PATIENT COMES NEAR A MAGNETIC INTERFERENCE. THE POR WAS CLEARED WITH THE PHYSICIAN PROGRAMMER. IMPEDANCES WERE RAN WHICH WERE ALL WITHIN NORMAL LIMITS. THE PATIENT STATED THAT THEY WANT A POCKET REVISION BECAUSE THEY LOST A LOT OF WEIGHT SO THEY WOULD CONTACT THEIR HEALTHCARE PROFESSIONAL (HCP) WHEN THEY WERE READY TO HAVE THEIR POCKET REVISED. THE PATIENT¿S MEDICAL HISTORY INCLUDES FAILED BACK SURGERY SYNDROME, SPINAL CORD STIMULATION, AND CHRONIC PAIN. THE REP AND HCP HAVE NO FURTHER INFORMATION TO PROVIDE. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620713 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR