BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955390 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01372
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCT: 4076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD. THE REMOTE MONITORING TRANSMISSION SHOWED NOISE, AN ELEVATED SHORT INTERVAL COUNTS (SIC) AND THE IMPEDANCE OF THE PACE/SENSE PORTION WAS GREATER THAN 3000 OHMS. A FRACTURE OF THE PACE/SENSE PORTION WAS SUSPECTED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58740 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R D274DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR