BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2952035 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00118
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 10, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015/S013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A 4469 COMPETITOR NON-DEFIB LEAD: (B)(6) 2009; 4068 NON-DEFIB LEAD: (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS KNOWN IMPEDANCE AND DECREASED CAPTURE THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55784 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D224DRG DEFIBRILLATOR