BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6026275 · Received October 13, 2016

    Report

    Report Number
    3004209178-2016-21700
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID: 377775, LOT# V003642, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# V003642, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE SITE INDICATED THAT NOT ALL IMPEDANCES WERE IN RANGE. THE DEVICE DIAGNOSIS WAS HIGH IMPEDANCE. THE OUTCOME WAS UNRESOLVED WITH NO FURTHER ACTION PLANNED. NO ACTION WAS PLANNED AS INTERVENTION. THE DEVICE WAS INTERROGATED AND IT SHOWED HIGH IMPEDANCES. THE ETIOLOGY WAS REPORTED AS RELATED TO THE DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE. THE HIGH IMPEDANCE WAS NOTED AT IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. THE ELECTRODES AFFECTED WERE NOT PART OF THE PATIENT'S PROGRAMMING. THEREFORE NO INTERVENTIONS WERE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678791 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1