BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 12626094 · Received October 13, 2021

    Report

    Report Number
    2182208-2021-04078
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    April 5, 2021
    Report Date
    October 13, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: BRAND NAME: MICRA, MODEL #: MC1VR01-DELSYS, EXPIRATION DATE: UNKNOWN, SERIAL#: UNKNOWN, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEV RTN TO MFR? NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE: YES. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/79 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LEFT FEMORAL VENOUS ACCESS FOR LEADLESS PACEMAKER IMPLANTATION: PATIENT CHARACTERISTICS AND OUTCOMES. EUROPACE (2021) 23, 1456¿1461. DOI:10.1093/EUROPACE/EUAB083. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING LEFT FEMORAL VENOUS ACCESS FOR LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED VENOUS BLEEDING WHICH REQUIRED MANUAL COMPRESSION AND PROLONGED HOSPITAL STAY AND ARTERIAL BLEEDING AFTER PUNCTURE WHICH REQUIRED COVERED STENTING. SOME PATIENTS DEVELOPED PERICARDIAL EFFUSIONS, SOME WERE MANAGED CONSERVATIVELY AND ONE REQUIRED DRAINAGE. THERE WERE LEADLESS IPGS WHICH EXHIBITED DECREASES IN IMPEDANCE. ONE PATIENT'S DEVICE EXHIBITED ELEVATED THRESHOLDS APPROXIMATELY TWO WEEKS AFTER IMPLANT AND CONTINUED TO INCREASE OVER TIME WHICH LED TO A DEVICE REMOVAL AND IMPLANT OF A TRANSVENOUS SYSTEM. THE STATUS/DISPOSITION OF THE DEVICES IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522646 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R