BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6159598 · Received December 9, 2016

    Report

    Report Number
    2182208-2016-02627
    Event Type
    Death
    Date Received
    December 9, 2016
    Date of Event
    January 1, 2016
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. 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 DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 66 YEARS OLD. 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: REDUCTION OF INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPIES AND SHOCKS BY A NOVEL SUITE OF DETECTION ALGORITHMS IN HEART FAILURE PATIENTS WITH CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS: A HISTORICAL COMPARISON OF A PROSPECTIVE DATABASE. EUROPACE. 2016;18(9):1391-8. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WHICH INDICATED THAT NONE OF THE DEATHS WERE DEVICE-RELATED.

    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, DEVICES WITH INAPPROPRIATE DETECTIONS, REPORTS OF ELECTROMAGNETIC INTERFERENCE (EMI), AND T-WAVE OVERSENSING (TWOS). THERE IS NO ALLEGATION THAT THE DEATHS WERE DEVICE-RELATED. THE STATUS OF THE DEVICE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION AND ANY ADDITIONAL INFORMATION PERTAINING TO THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813534 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| L| R IMPLANTABLE TACHY LEAD