BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-07581

    MDR report key: 2161207 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07581
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 1, 2004
    Report Date
    April 14, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE REVIEW OF A RECENTLY PUBLISHED JOURNAL ARTICLE, THE FOLLOWING JOURNAL ARTICLE WAS REVIEWED: RALF KOOS, MD, ANIL-MARTIN SINHA, MD, KAI MARKUS, MD, OLE-ALEXANDER BREITHARDT, MD, KARL MISCHKE, MD, MARKUS ZARSE, MD, MICHAEL SCHMID, MD, RU¨DIGER AUTSCHBACH, MD, PETER HANRATH, MD, AND CHRISTOPH STELLBRINK, MD. COMPARISON OF LEFT VENTRICULAR LEAD PLACEMENT VIA THE CORONARY VENOUS APPROACH VERSUS LATERAL THORACOTOMY IN PATIENTS RECEIVING CARDIAC RESYNCHRONIZATION THERAPY. THE AMERICAN JOURNAL OF CARDIOLOGY. VOL. 94, JULY 1, 2004: 59-63. REVIEW OF THIS ARTICLE INDICATED THAT 50 PATIENTS WERE IDENTIFIED AS HAVING HAD A GUIDANT (NOW BOSTON SCIENTIFIC) LEFT VENTRICULAR (LV) LEAD IMPLANTED. IT WAS REPORTED THAT DURING THE COURSE OF THE STUDY, THE FOLLOWING NON-SPECIFIC PRODUCT ISSUES WERE IDENTIFIED: A CORONARY SINUS DISSECTION WITH NO ADVERSE EFFECTS, TWO LV LEAD DISLODGEMENTS, THREE ATRIAL LEAD DISLODGEMENTS, AN ATRIAL LEAD FRACTURE, AND AN UNIDENTIFIED DISLOCATED DEVICE. THE STUDY ALSO REPORTED SEVEN PATIENTS PASSED AWAY DURING THE COURSE OF THE ONE-YEAR STUDY, BUT DID NOT INDICATE OR ALLEGE ANY OF THE DEATHS WERE ASSOCIATED WITH ONE OR MORE OF THE IDENTIFIED PRODUCTS. AN ATTEMPT TO CONTACT THE AUTHOR LISTED AS THE ARTICLE'S CONTACT FOR ADDITIONAL DETAIL OR SPECIFIC INFORMATION WAS RETURNED AS UNDELIVERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other