BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153194 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05869
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT CONTINUED: D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2009; 419688 IMPLANTABLE PACING LEAD (B)(6) 2009; 407645 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM AFTER HEARING AN ALARM EVERY FOUR HOURS. THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC) WITH NOISE DUE TO A LEAD FRACTURE. THE LEAD WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256040 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R