BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-18166

    MDR report key: 1873945 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18166
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A LOCAL FIELD REPRESENTATIVE (FR) THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD AND THE ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) UNDERWENT A ROUTINE PULSE GENERATOR (PG) CHANGE-OUT. THE FR WAS NOT PRESENT FOR THE PROCEDURE, HOWEVER STATED THE PHYSICIAN PERFORMING THE PROCEDURE HAD CALLED TO REPORT A PRODUCT EXPERIENCE. THE FR REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY WITH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) RATE/SENSE SETSCREWS WHICH RESULTED IN DESTRUCTION OF BOTH LEADS DURING THE PROCEDURE. A NEW RV LEAD WAS PLACED AND THE PATIENT WAS TO BE SENT TO HAVE THE OTHER LEADS EXTRACTED. THE FR WAS NOT ABLE TO ATTAIN ADDITIONAL INFORMATION REGARDING THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention