BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTAC INTRODUCER ACCESSORY FOR MYOPORE LEAD

    MDR report key: 2012236 · Received February 2, 2011

    Report

    Report Number
    2183787-2011-00013
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED BY (B)(4). THE DISTRIBUTOR, (B)(4), AND THE SALES REPRESENTATIVE BELIEVES THAT IT IS VERY LIKELY THAT THE PHYSICIAN HAD TO DETACH AND RE-ATTACH THE INTRODUCER TO THE DISTAL END OF THE LEAD DURING IMPLANTATION SINCE HE HAD TO RE-POSITION THE LEAD DURING THE IMPLANTATION PROCEDURE. AN INTRODUCER WAS RETURNED TO (B)(4) MEDICAL, BUT IT IS NOT THE SAME INTRODUCER THAT WAS PART OF THIS EVENT. IT IS UNCLEAR WHAT THE SERIAL NUMBER OR LOT NUMBER FOR THE INTRODUCER INVOLVED WITH THE EVENT IS. ATTEMPTS TO RETRIEVE INFORMATION ABOUT THE SERIAL AND LOT NUMBERS WERE UNSUCCESSFUL. ATTEMPTS TO RECEIVE MORE INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL. THERE WERE NO ISSUES WITH THE INTRODUCER THAT WAS RETURNED TO (B)(4) MEDICAL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING IMPLANT, THE SHAFT WAS DISMOUNTED FROM THE INTRODUCER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SMALL SPRING, WHICH IS INTEGRATED IN THE INTRODUCER FOR THE MYOPORE LEAD BECAME DETACHED DURING ATTEMPTED IMPLANTATION OF THE EPICARDIAL LEAD. THE PHYSICIAN WAS ABLE TO FIND THE SPRING SO NO DANGER TO THE PATIENT OCCURRED AND THE PATIENT IS DOING WELL. THE PHYSICIAN STATED THAT THIS WAS THE SECOND TIME THAT HE WAS EXPERIENCED THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTAC INTRODUCER ACCESSORY FOR MYOPORE LEAD FASTAC INTRODUCER TOOL DTB GREATBATCH MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other