BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM

    MDR report key: 8547026 · Received April 24, 2019

    Report

    Report Number
    2183787-2019-00030
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 8, 2019
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    UDI-DI
    00821329900228
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS NOT EVALUATED. THE DEVICE WENT THROUGH AT LEAST ONE DECONTAMINATION PROCEDURE USING A HIGH-LEVEL DISINFECTANT (I.E. CIDEX OPA) IN ACCORDANCE WITH ITS MANUFACTURER'S RECOMMENDATIONS AND THEREFORE, MOST IF NOT ALL MICROORGANISMS WERE ELIMINATED FROM THE DEVICE. SINCE INFECTION RESULTS FROM THE PRESENCE OF MICROORGANISMS, ADDITIONAL TESTING TO ATTEMPT TO IDENTIFY THE SOURCE OF INFECTION IS NOT FEASIBLE.

    Description of Event or Problem · 1

    AS REPORTED: THE PATIENT WAS IMPLANTED ON (B)(6) 2019 WITH A NON GREATBATCH MEDICAL UNIFY ASSURA (3357-40Q, SN: (B)(4)) AND A NON GREATBATCH MEDICAL RIGHT ATRIAL LEAD (LPA1200M, SN: (B)(4)) AND NON GREATBATCH MEDICAL RIGHT VENTRICULAR LEAD (7122Q, SN: (B)(4)). LATER TWO EPICARDIAL LEFT VENTRICULAR LEADS WERE IMPLANTED (NON-GREATBATCH MEDICAL IN USE - 4968, SN: (B)(4); BACKUP GREATBATCH MEDICAL - 511212, SN: (B)(4)) ON (B)(6) 2019. THE FOLLOWING PHYSICIAN NOTIFIED THE ST. JUDE REP THAT THE PATIENT WOULD HAVE THE DEVICE, RA, AND RV LEADS EXPLANTED ON (B)(6) 2019 DUE TO AN INFECTION AND THAT THE EPICARDIAL LEADS WOULD EITHER BE CUT OR LEFT AS IS DURING THE PROCEDURE. ALL OF THE LEADS CURRENTLY IN USE ARE STABLE AND FUNCTIONING APPROPRIATELY. THE PATIENT REMAINS ADMITTED AT THE HOSPITAL UNTIL THE SCHEDULED EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337569 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W4090773 00821329900228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention