BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 5559563 · Received April 7, 2016

    Report

    Report Number
    2182208-2016-00996
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    January 1, 2015
    Report Date
    February 16, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: AN UNUSUAL CAUSE OF RECURRENT SYNCOPE IN A PATIENT WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. 2015;15(4):213-215. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT¿S IMPLANTED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE ARTICLE INDICATED THAT THE PATIENT COMPLAINED OF ¿RECURRENT SYNCOPAL EPISODES¿ WHILE STANDING AND WITH NO PALPITATIONS. THE PATIENT¿S DEVICE WAS INTERROGATED AND THERE WERE MULTIPLE EPISODES OF NOISE FOUND. THIS RESULTED IN VENTRICULAR PACING INHIBITION WITH PAUSES. THE PACING THRESHOLDS AND IMPEDANCE OF THE LEADS WERE ALL NORMAL. THERE WERE SOME ¿FAST NON-SUSTAINED VENTRICULAR TACHYCARDIAS (VTS) WITH VERY SHORT NON-PHYSIOLOGICAL R-R INTERVALS¿ PRIOR TO THE SYNCOPAL EPISODES. THE DEVICE¿S LEAD INTEGRITY ALERT ALGORITHM CORRECTLY IDENTIFIED THE NOISE. THE PATIENT INDICATED THAT A ¿BEEP¿ WAS HEARD FROM THE DEVICE, BUT ¿OVERLOOKED¿ IT. THE DEVICE¿S ADDITIONAL ALGORITHM DID NOT TRIGGER FOR THE LEAD NOISE DISCRIMINATION. THE DEVICE WAS MANIPULATED AND THIS FAILED TO GENERATE THE NOISE. THE PATIENT EXPLAINED THAT ALL THE EPISODES OCCURRED AT APPROXIMATELY 2:00 P.M.; THIS IS THE TIME THE PATIENT WOULD GO INTO THE LAUNDRY ROOM. FURTHER INVESTIGATION REVEALED THAT THE WASHING MACHINE WAS NOT ¿PROPERLY GROUNDED.¿ THE ARTICLE STATED THAT ONCE THE WASHING MACHINE WAS REPAIRED, THERE WERE NO MORE SYNCOPAL EPISODES. THE SYSTEM REMAINS 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
    211338 PROTECTA XT CRT-D PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention IMPLANTABLE TACHY LEAD