BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1863587 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15330
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 19, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0906-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE ICD HAS BEEN RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THAT THE DEVICE HEADER WAS LOOSE. ADDITIONALLY, THE SEVERAL OF THE FEED THRU WIRES WERE FOUND TO BE SEVERED. DETAILED ANALYSIS REVEALED THAT THE WIRES MOST LIKELY INTACT WHILE THE ICD WAS IMPLANTED AND BECAME SEVERED DURING THE EXPLANT PROCEDURE AS EACH WIRE EXHIBITED THE SAME TYPE OF TWISTING DAMAGE. THIS WAS ALSO CONFIRMED AFTER A REVIEW OF THE DEVICE MEMORY FOUND NO OUT OF RANGE MEASUREMENTS OR ANY ANOMALIES ASSOCIATED WITH THE HEADER BECOME LOOSE WHILE IMPLANTED. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN CAUSING THE HEADER TO BECOME LOOSE, THE ROOT CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. MANUFACTURING ENHANCEMENTS WERE IMPLEMENTED IN 2003 TO MAKE THE BOND MORE ROBUST. THIS DEVICE WAS MANUFACTURED PRIOR TO THE MANUFACTURING CHANGES.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE NORMAL EXPLANTATION PROCEDURE FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE HEADER COMPLETELY DETACHED ITSELF FROM THE DEVICE CASE ONCE IT WAS REMOVED FROM THE POCKET. THIS ICD HAD BEEN IMPLANTED UNDER THE PECTORAL MUSCLE AND WAS REMOVED WITH A GRASPING TOOL. IT IS UNKNOWN IF THE HEADER HAD LOOSENED WHILE IT WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 Other