BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6318946 · Received February 9, 2017

    Report

    Report Number
    2182208-2017-00326
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    November 9, 2016
    Report Date
    December 8, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS AND MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO DEVICE/PRODUCT FAILURE CORRELATION/SERIAL NUMBERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS APPROXIMATELY 75 YEARS OLD. 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: "TRANSCATHETER LEADLESS CARDIAC PACING: THE NEW ALTERNATIVE SOLUTION. INT J CARDIOL. 2017;227:122-126."

    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 TRANSCATHETER PACING SYSTEMS (TPS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTED THAT ONE PATIENT EXHIBITED CARDIO-CIRCULATORY ARREST RELATED TO A VENTRICULAR FIBRILLATION (VF) ONE DAY POST-IMPLANTATION, WITH SINUS RHYTHM RESTORED BY CARDIOVERSION. THE DEVICE EXHIBITED NORMAL PARAMETERS. IT WAS DETERMINED THAT THE PATIENT EXPERIENCED SEVERE RIGHT-VENTRICULAR DYSFUNCTION WITH PULMONARY HYPERTENSION AND SEVERE TRICUSPID REGURGITATION. IT WAS NOTED THAT THE PATIENT RECEIVED A SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR. THE STATUS OF THE DEVICES IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101588 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R