BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCTUA

    MDR report key: 3053567 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05277
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE REMAINS IN SERVICE AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC, THEREFORE THE CLINICAL OBSERVATIONS CAN NO BE CONFIRMED BY ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED HIGH SHOCK IMPEDANCE GREATER THAN 200 OHMS (THE MODEL AND SERIAL NUMBER OF THE RIGHT VENTRICULAR (RV) LEAD ARE UNKNOWN AT THIS TIME AND ATTEMPTS HAVE BEEN MADE TO OBTAIN). THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AWAITING A REVISION PROCEDURE. THE NEXT DAY, A REVISION PROCEDURE WAS PERFORMED. DURING THE IMPLANT PROCEDURE THE PHYSICIAN OBSERVED THAT THE RIGHT VENTRICULAR (RV) LEAD PIN HAD DISCONNECTED ITSELF FROM THE DEVICE. THE LEAD WAS PROPERLY RE-CONNECTED TO THE DEVICE AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156435 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R