BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

    MDR report key: 2313916 · Received October 28, 2011

    Report

    Report Number
    2953769-2011-00138
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    October 15, 2011
    Report Date
    October 15, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    BSP
    PMA / PMN Number
    K073516
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IN HIS (B)(6) UNDERWENT A TWO-LEVEL FAD PROCEDURE AT LEVELS L2/3 AND L4/5. THE CASE PROCEEDED WITHOUT INCIDENT; HOWEVER, THE NEXT DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN APPARENT INFECTION OF THE HEART. THE PHYSICIAN BELIEVES THE FAD PROCEDURE AND INFECTION ARE UNRELATED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP MEDTRONIC SPINE LLC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization