BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153776 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06226
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. (B)(4): 4195 IMPLANTABLE PACING LEAD 2013-(B)(6), 5076 IMPLANTABLE PACING LEAD 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FEELING LIGHTHEADED AND DIZZY. THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND EXHIBITED COMPLETE LOSS OF CAPTURE. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAPTURING INTERMITTENTLY AND EXHIBITED HIGH THRESHOLDS. THE LV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255382 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR