BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, SJ4 CONNECTOR

    MDR report key: 1831116 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03586
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON DEVICE SETTINGS AND USAGE, THE DEVICE DID NOT MEET EXPECTED LONGEVITY. NO HIGH CURRENT DRAIN SOURCES WERE FOUND. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. NO SOURCES OF INTERNAL LOADING WERE FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT, THE BATTERY VOLTAGE READING WAS 2.48V WITH LESS THAN THREE MONTHS REMAINING LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED DEVICE FAILURE OCCURRED. THE DEVICE WAS REMOVED AN A SECOND AND THIRD PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. THE PUNCTURE SITE WAS BORDERLINE HIGH AT APPROXIMATELY THE TAKE OFF OF THE INFERIOR EPIGASTIC ARTERY. AFTER THE DEVICES WERE REMOVED A LARGE DISSECTION IN THE AREA OF THE PUNCTURE SITE WAS NOTICED. ANGIOPLASTY BALLOONING WAS PERFORMED UNSUCCESSFULLY TO TREAT THE DISSECTION. ARTERIAL SURGICAL REPAIR IS PLANNED; HOWEVER, EXACT DATE OF SURGERY IS UNKNOWN. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention