BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953295 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01065
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED NON-PHYSIOLOGIC OVERSENSING. THE AVERAGE V ENTRICULAR SHORT INTERVAL COUNT (V-SIC) INCREASED FROM <(><<)>1 COUNT/DAY TO 9.1 AVG COUNTS/DAY ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT THE OVERSENSING COULD BE DUE TO POSSIBLE DOUBLE COUNTING OF PREMATURE VENTRICULAR CONTRACTION (PVC) WAVES. THE LEAD REMAINS IN USE AND WILL BE CLOSELY MONITORED FOR LEAD ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT THE OVERSENSING COULD BE DUE TO POSSIBLE DOUBLE COUNTING OF PREMATURE VENTRICULAR CONTRACTION (PVC) WAVES. THE LEAD REMAINS IN USE AND WILL BE CLOSELY MONITORED FOR LEAD ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT THE OVERSENSING COULD BE DUE TO POSSIBLE DOUBLE COUNTING OF PREMATURE VENTRICULAR CONTRACTION (PVC) WAVES. THE LEAD REMAINS IN USE AND WILL BE CLOSELY MONITORED FOR LEAD ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57195 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR D274DRG IMPLANTABLE DEFIBRILLATOR