BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7196143 · Received January 16, 2018

    Report

    Report Number
    3004209178-2018-00818
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    February 8, 2016
    Report Date
    January 30, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL. IT WAS REPORTED THAT NO IMPEDANCE VALUES WERE OUT-OF-RANGE AFTER IMPLANT. THE IMPEDANCE RESULTS USING ELECTRODE 0 AS THE REFERENCE WERE: ELECTRODE 1 - 3205 OHMS, ELECTRODE 2 - 3263 OHMS, ELECTRODE 3 - 4931 OHMS, ELECTRODE 4 - 3728 OHMS, ELECTRODE 5 - 3565 OHMS, ELECTRODE 6 - 2418 OHMS, ELECTRODE 7 - 2536 OHMS, ELECTRODE 8 - 4399 OHMS, ELECTRODE 9 - 3747 OHMS, ELECTRODE 10 - 2832 OHMS, ELECTRODE 11 - 4036 OHMS, ELECTRODE 12 - 3766 OHMS, ELECTRODE 13 - 2854 OHMS, ELECTRODE 14 - 2510 OHMS, AND ELECTRODE 15 - 2410 OHMS. THE PATIENT'S BASELINE WEIGHT WAS PROVIDED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL OF A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. THE PATIENT REPORTED UNDESIRABLE PAIN ON (B)(6) 2016. THE PATIENT FELT STIMULATION AROUND THE ABDOMEN THROUGH HER STOMACH THAT WAS BOTHERSOME. THE PATIENT ALSO FELT SOME "SHOCKS" AROUND THE BATTERY SITE AND FELT IT IN HER LEG AND STOMACH. THE PATIENT ALSO COMPLAINED THE BATTERY SITE WAS VERY PAINFUL. THE CLINICAL DIAGNOSIS WAS BACK PAIN AND A DEVICE DIAGNOSIS WAS NOT APPLICABLE. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2016 AND THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37032 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR