BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953161 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00918
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 18, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 PRODUCTS : 4193, IMPLANTABLE PACING LEAD, (B)(6) 2010; 6947, IMPLANTABLE TACHY LEAD, (B)(6) 2011; 5076, IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT RECEIVED TWO SHOCKS FROM THE RIGHT VENTRICULAR LEAD DUE TO A LEAD FRACTURE AND A (PACE/SENSE IMPEDANCE) "READING UP OVER 3000" (OHMS.) THE PATIENT ALSO REPORTS NOW BEING "PARANOID OF ELECTRICAL STORMS" AND THAT THEEVENT CAUSED "PAIN AND SUFFERING." THE LEAD WILL BE REPLACED HOWEVER IT IS STILL 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
    56695 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| L (B)(4) IMPLANTABLE DEFIBRILLATOR