BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 5623906 · Received May 2, 2016

    Report

    Report Number
    2182208-2016-01403
    Event Type
    Death
    Date Received
    May 2, 2016
    Date of Event
    December 1, 2015
    Report Date
    July 31, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS 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 PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). 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: ELECTRICAL STORM IN PATIENTS WITH IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IN THE ERA OF CATHETER ABLATION: IMPLICATIONS FOR BETTER RHYTHM CONTROL. HEART RHYTHM. 2015;12(12):2419-25.

    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 WITH THE AUTHOR WHO INDICATED THAT THERE WERE THREE (3) OF THIS MANUFACTURER'S DEVICES USED AND NONE WERE RELATED TO THE PATIENT DEATHS, NOR WERE THERE ANY "PRODUCT SPECIFIC COMPLICATIONS" AMONG THE THE PATIENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENT DEATHS AND PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPIES DUE TO T-WAVE OVERSENSING. OF NOTE, ELECTRICAL STORM IN PATIENTS ALSO WAS SEEN. THE AUTHOR DID NOTE THAT THE INAPPROPRIATE THERAPIES WERE DELIVERED "MOSTLY DURING HIGH-RATE EPISODES OF ATRIAL FIBRILLATION (AF) OR SUPRA-VENTRICULAR TACHYCARDIA." THE STATUS OF THE DEVICE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THERE IS NO ALLEGATION OF DEVICE-DEATH RELATEDNESS INDICATED IN THE ARTICLE; HOWEVER, THE CAUSE OF DEATH AND DEVICE-RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279040 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| L| R