BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6919931 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01493
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    April 25, 2001
    Report Date
    July 26, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MULTIPLE PATIENTS AND MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION/SERIAL NUMBERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS FEMALE AND THE BASELINE AGE IS APPROXIMATELY 70 YEARS OLD. POSSIBLE MODELS COULD INCLUDE: 5068; 5072; 5568. 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: PREVENTION OF CHRONIC ATRIAL FIBRILLATION BY PACING IN THE REGION OF BACHMANN¿S BUNDLE: RESULTS OF A MULTICENTER RANDOMIZED TRIAL. J CARD ELECTROPHYS 2001;12:912- 917.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PACING LEADS. 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 PATIENTS EXPERIENCED HEMATOMA, PERICARDIAL EFFUSION, CONGESTIVE HEART FAILURE, MYOCARDIAL INFARCTION, SEIZURES, CHEST PAIN AND AORTIC/FEMORAL BYPASS. IT WAS NOTED THAT SOME PATIENTS REQUIRED POCKET REVISION AND VENTRICULAR LEAD POSITIONING. THE STATUS OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702179 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R