BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 4968039 · Received August 4, 2015

    Report

    Report Number
    3005619263-2015-00013
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: (B)(4) ICD, (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT TOOK OFF THE STERI-STRIPS FROM THE IMPLANT SITE AND ACCIDENTALLY HIT THE POCKET WITH A SHOVEL HANDLE WHILE WORKING OUTSIDE. THE ABSORBABLE ENVELOPE, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND LEADS WERE EXPLANTED AND THE SYSTEM WAS REPLACED APPROXIMATELY ONE MONTH LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506945 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 5076-45 LEAD, 419688 LEAD, 694765 LEAD