BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6173483 · Received December 14, 2016

    Report

    Report Number
    2182208-2016-02918
    Event Type
    Death
    Date Received
    December 14, 2016
    Date of Event
    January 1, 2014
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE PACING LEAD-ATRIAL. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE FOR THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/(B)(6). THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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. POSSIBLE MODELS INVOLVED COULD INCLUDE D154AWG AND/OR D154VWC. NO FURTHER INFORMATION IS AVAILABLE. REFERENCED ARTICLE: A PROSPECTIVE RANDOMIZED TRIAL OF SINGLE- OR DUAL-CHAMBER IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS TO MINIMIZE INAPPROPRIATE SHOCK RISK IN PRIMARY SUDDEN CARDIAC DEATH PREVENTION. EUROPACE. 2014;16(10):1460-1468. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENT DEATHS REFERENCED. THERE WERE ALSO PATIENTS WITH INAPPROPRIATE SHOCKS, INFECTION/EROSION, PERICARDIAL EFFUSION, PHLEBITIS/THROMBOSIS/EMBOLISM, AND CEREBRAL VASCULAR ACCIDENT (CVA)/TRANSIENT ISCHEMIC ATTACK (TIA). THERE WERE ALSO REPORTED DEVICE-RELATED VENTRICULAR LEAD DISLODGEMENTS, AND ATRIAL AND VENTRICULAR OVERSENSING, AND ATRIAL FAILURE TO CAPTURE OBSERVED. THERE IS NO ALLEGATION THAT THE DEATHS WERE DEVICE-RELATED. THE STATUS OF THE DEVICE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824829 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| L| R IMPLANTABLE TACHY LEAD-VENTRICULAR