BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7452232 · Received April 23, 2018

    Report

    Report Number
    3004209178-2018-08623
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    April 19, 2018
    Report Date
    May 10, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. PRODUCT ID 3888-33, LOT# V096187, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. PRODUCT ID 3888-33, LOT# V020235,IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN VIA A MAN UFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THERE WERE HIGH IMPEDANCES ON ELECTRODES 1 AND 15. THE REP REPORTED THAT THE PATIENT FELL ¿A FEW WEEKS AGO¿ BUT THESE ELECTRODES WERE NOT IN USE. THE REP REPORTED THAT THEY CHECKED IMPEDANCES AND THESE ELECTRODES WERE NOT USED SO NO CHANGES WERE MADE TO PROGRAMMING. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE MANUFACTURER REPRESENTATIVE INDICATED THAT THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295389 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR