BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 3041161 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01379
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 15, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. WHEN THE POCKET WAS OPENED, VISUAL OBSERVATION REVEALED THIS LEAD WAS ABLE TO MOVE IN THE SUTURE SLEEVE. NO CONNECTION ISSUE WAS NOTED. A DECISION WAS MADE TO REPLACE THIS LEAD. THIS LEAD WAS REMOVED. AN ATTEMPT TO REPLACE THIS LEAD WAS UNSUCCESSFUL AND THE LEFT VENTRICULAR PORT WAS PLUGGED. REPLACED WITH A NON-BOSTON SCIENTIFIC LEAD SUCCESSFULLY AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS LEFT VENTRICULAR LEAD, DIFFICULTY WAS ENCOUNTERED OBTAINING A STABLE POSITION. ONE MONTH LATER, THIS LEAD WAS SUSPECTED DISLODGED BUT REMAINED IN THE TARGET VEIN. IN ADDITION, INCREASED THRESHOLD MEASUREMENTS WERE OBTAINED. AN ELECTROGRAM REVEALED LOSS OF BIV PACING. A REVISION PROCEDURE IS INTENDED IN THE NEAR FUTURE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED FURTHER LEAD INTEGRITY TESTING. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143407 IMPLANTABLE LEAD OJX GUIDANT PUERTO RICO BV

    Patients

    Seq Age Sex Outcome Treatment
    1