BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955339 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01449
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PRODUCT: 5076 IMPLANTABLE PACING LEAD 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE HOSPITAL FOR A FRACTURED HIP THE PATIENT RECEIVED TWO SHOCKS FORM THE RIGHT VENTRICULAR (RV) LEAD DUE TO OVERSENSING. IT WAS ALSO REPORTED THAT THE PATIENT DOES NOT RECALL RECEIVING THE SHOCKS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59633 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Life Threatening (B)(4) IMPLANTABLE PACEMAKER CARDIO/DEFIB