BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7746928 · Received August 3, 2018

    Report

    Report Number
    3004209178-2018-17347
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    May 29, 2018
    Report Date
    October 3, 2018
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    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 REPORTED THAT THE CAUSE OF THE PATIENT'S HIGH IMPEDANCES AND LOSS OF STIMULATION WAS NOT DETERMINED. THE PATIENT'S OFFICE HAS ORDERED DIAGNOSTIC IMAGING. THERE HAS BEEN NO LEAD REVISION PLANNED OR SCHEDULED. THE PATIENT'S HIGH IMPEDANCES AND LOSS OF STIMULATION HAS NOT BEEN RESOLVED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CHRONIC LOW BACK PAIN, RADICULOPATHY, AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS ONLY 'TOUCHING THE LEFT SIDE AND NOT WORKING ON THE RIGHT SIDE' AND THAT THEY WOULD LIKE MORE COVERAGE ONTHE RIGHT SIDE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION ABOUT 6 MONTHS AGO AND ONLY HAS STIMULATION IN THE UPPER LEFT THIGH AND BEHIND THE KNEE. AN IMPEDANCE TEST WAS PERFORMED AND THE FOLLOWING RESULTS WERE OBTAINED: 1 19031 OHMS 2 22733 3 16711 4 40K 5 30689 6 18260 7 15109 8 20383 9 18582 10 17948 11 19870 12 19870 13 21943 14 40K 15 17451 OHMS IT WAS NOTED THAT CONTACTS 4 AND 14 HAD IMPEDANCES OF OVER 40K OHMS. THE PATIENT WAS REDIRECTED TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER FOR A REVISION. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587384 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR