BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS DR

    MDR report key: 1033752 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00446
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    January 23, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DISTAL PART OF THE THIRD-PARTY LEAD WAS ATTACHED TO THE PACEMAKER'S VENTRICULAR PLUG. THE LEAD ATTACHMENT SCREW HAD NOT BEEN FULLY TIGHTENED. THE DISTAL LEAD PIECE WAS REMOVED. THE VENTRICULAR LEAD ATTACHMENT SCREW COULD BE EASILY SCREWED IN AND OUT. CONTACT WEAR ON THE LOWER SIDE OF THE LEAD ATTACHMENT SCREW COULD BE DETECTED. THIS IS AN INDICATION THAT THIS PART OF THE LEAD PLUG HAD CONTACT AT LEAST ONCE, AS PER THE INTENDED USE. THE ANALYSIS REVEALED BODY FLUID RESIDUE WITHIN THE LEAD CONNECTOR INPUTS. IN SPITE OF THE FLUID, THE TEST LEADS COULD BE RELIABLY CONTACTED. DURING THE INITIAL INTAKE TEST, IT WAS DETERMINED THAT THE PACEMAKER WAS PROGRAMMED TO DDD MODE WITH A RATE OF 60 PPM. ATRIAL PULSE AMPLITUDE WAS 2.5 V AND 0.4 MS. THE VENTRICLE WAS PROGRAMMED TO A PULSE AMPLITUDE OF 6.0 V WITH A PULSE WIDTH OF 1 MS. BOTH CHANNELS HAD BIPOLAR SENSING AND PACING POLARITIES PROGRAMMED. A FULL PACEMAKER FUNCTION TEST WAS PERFORMED AND NO DISCREPANCIES COULD BE FOUND. PACEMAKER PACING AND SENSING FUNCTIONS WERE TESTED. THERE WERE NO DEFECTS IN THE PACING AND SENSING. A BIPOLAR TEST LEAD WAS ALSO SUCCESSFULLY CONTACTED AND BIPOLAR PACING WAS MEASURED WITHOUT ANY INTERMITTENT INTERRUPTIONS IN CONTACT. THE THIRD-PARTY DISTAL LEAD PIECE WAS ELECTRICALLY TESTED. THE IMPEDANCE OF THE LEAD WAS CONSTANT. NO SHORT-CIRCUIT BETWEEN THE LEADS WAS FOUND. THE LEAD SHOWED VARYING IMPEDANCE. THE LEAD WAS RETURNED TO THE MFR FOR FURTHER TESTING. IN SUMMARY, THE PACEMAKER ANALYSIS RESULTS DO NOT INDICATE A MATERIALS OR MANUFACTURING DEFECT. THE PACEMAKER IS WITHIN ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF APPROX. 14 MONTHS, AN EXIT BLOCK WAS REPEATEDLY REPORTED. THE EXIT BLOCK CAUSED PT SYNCOPE. THE PACEMAKER WAS SUBMITTED WITH A THIRD-PARTY LEAD. THE PHYSICIAN CONFIRMED THE EXIT BLOCK WHEN THE LEAD WAS UNDER MECHANICAL TENSION DURING AN INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO 122450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization