BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD LEAD

    MDR report key: 3011596 · Received March 19, 2013

    Report

    Report Number
    6000153-2013-00040
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT HAD "REDNESS, SWELLING, AND PAIN" "BELOW HER LEAD SITE" WHICH HAD "INFRAORBITAL PLACEMENT." THE INFECTION LOCATION WAS ALSO STATED AS AT THE "CATHETER OR LEAD TRACK." THE PATIENT WAS ADMINISTERED "BOTH ORAL AND INTRAVENOUS ANTIBIOTICS." CULTURES TAKEN FROM THE "DEVICE POCKET" WERE REPORTED AS "NEGATIVE CULTURE" TYPES. IT WAS ALSO NOTED THAT THE PATIENT DID NOT HAVE MENINGITIS. IT WAS STATED THAT THE PATIENT UNDERWENT A "TOTAL DEVICE SYSTEM EXPLANT." FURTHER INFORMATION WAS NOT KNOWN AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113647 STANDARD LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3777 VA05CGY002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention