BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICARDIAL PATCH

    MDR report key: 1864829 · Received October 12, 2010

    Report

    Report Number
    2182208-2010-00786
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 2, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT FOR IMPEDANCE OF 19 OHMS. IT WAS ALSO REPORTED THAT BOTH LEADS HAD LOW IMPEDANCES. BOTH LEADS ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICARDIAL PATCH IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6721L ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other 5071 (X2) IMPLANTABLE PACING LEAD| 4968 (X2) IMPLANTABLE PACING LEAD| D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB