BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5519992 · Received March 23, 2016

    Report

    Report Number
    3004209178-2016-05180
    Event Type
    Injury
    Date Received
    March 23, 2016
    Report Date
    March 23, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# V011299, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET GOT INFECTED. THE PATIENT WAS SEEN BY THE DOCTOR AND THE WOUND HAD OPENED UP AND WAS DRAINING. IT WAS UNKNOWN WHEN THE INFECTION STARTED. THE DEVICE WAS REMOVED AND THE LEADS WERE CUT BUT LEFT IN PLACE. IT WAS NOTED THAT IT WAS PROBABLE THAT THE SYSTEM WOULD BE REPLACED AT A LATER DATE ONCE THE INFECTION HAD CLEARED. AT THIS POINT THE LEADS WOULD BE REPLACED. THE PATIENT WAS IMPLANTED FOR SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175032 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention