BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4831349 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05584
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE FRACTURE, HIGH IMPEDANCE, HIGH THRESHOLDS AND WAS UNABLE TO CAPTURE AT THE HIGHEST OUTPUT. THE RV LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT DURING THE PLACEMENT OF THE LEFT VENTRICULAR (LV) LEAD, THE REPLACEMENT RV LEAD DISLODGED. WHEN THE PHYSICIAN TRIED TO REPOSITION THE RV LEAD, THE HELIX WAS RETRACTED AND UPON PLACING IN A NEW POSITION WOULD NOT EXTEND. THE REPLACEMENT RV LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373432 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization| R D314TRG BI-V ICD/6725 ADAPTOR/5076-52 LEAD