BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R MEDIUM

    MDR report key: 6319325 · Received February 9, 2017

    Report

    Report Number
    3005619263-2017-00011
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    August 1, 2016
    Report Date
    May 9, 2018
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: A 5076-52 LEAD, IMPLANTED: (B)(6) 2009. PRODUCT ID: A 5076-58 LEAD, IMPLANTED: (B)(6) 2009. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: EVALUATION CODES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE VISITS FOR WOUND ISSUES AT THE INCISION SITE. THE ISSUES BEGAN APPROXIMATELY SIX WEEKS AFTER A ROUTINE DEVICE EXCHANGE PROCEDURE, DURING WHICH AN ABSORBABLE ENVELOPE WAS ALSO IMPLANTED. THE PATIENT PRESENTED WITH PAIN, REDNESS AND PURULENT POCKET DRAINAGE. DEVICE EROSION AND AN INFECTION WERE NOTED AND A THROMBUS WAS IDENTIFIED VIA ECHOCARDIOGRAM. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND WAS NOT REPLACED. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE (B)(6) TRIAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT POST EXPLANT OF THE INFECTED SYSTEM, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH BLEEDING/DRAINAGE FROM A HEMATOMA AT THE IMPLANT SITE. THE SUTURES WERE REMOVED, AND THE HEMATOMA WAS EXPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101226 AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122 16E05728

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R A2DR01 IPG