BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3781571 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08260
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    June 19, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALY. ANALYSIS OF THE WRENCH FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_WRENCH_ACC, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCES WERE HIGH AT 10000 OHMS. IT WAS NOTED THAT THE REPORTER EXCHANGED THE LEADS AND CHECKED THE IMPEDANCES ON 10 OCCASIONS. IT WAS NOTED THAT A TRIALING CABLE WAS THEN USED TO CHECK THE IMPEDANCES AND ALL WERE WITHIN RANGE. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS THEN EXCHANGED AND THE IMPEDANCES WERE THEN IN RANGE FOR ALL ELECTRODES. IT WAS NOTED THAT THE PRODUCT WOULD BE RETURNED. IT WAS NOTED THAT THE PATIENT AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT AND THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259712 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR