BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUADRIPOLAR PTO 5L

    MDR report key: 3151978 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05575
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: D154VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL HIGH IMPEDANCE RIGHT VENTRICULAR PATIENT ALARMS WERE OBSERVED OVER A PERIOD OF APPROXIMATELY ONE YEAR.AT THE LAST FOLLOW UP RIGHT VENTRICULAR LEAD IMPEDANCE > 2000 OHM WAS OBSERVED. THE PATIENT IS FOLLOWED UP REGULARLY IN ORDER TO FURTHER MONITOR RIGHT VENTRICULAR IMPEDANCE RISE. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253308 SPRINT QUADRIPOLAR PTO 5L DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1