BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5403332 · Received February 1, 2016

    Report

    Report Number
    3004209178-2016-01335
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. THE REP WANTED TO KNOW IF THERE WERE GUIDELINES IF HE COULD NOT GET THE LEAD OUT AND IF HE COULD LEAVE IT IN. THE PATIENT WAS GOING INTO SURGERY TONIGHT AND THE REP WANTED TO KNOW IF HE SHOULD REMOVE THE LEADBECAUSE OF THE INFECTION. IT WAS NOTED THAT WAS ALSO DRAINAGE. THE INFECTION WAS CULTURED AND POSITIVE FOR INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS ONCE AND THE INFECTION CAME BACK. IT WAS UNKNOWN WHEN THE INFECTION DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60733 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention