BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811265 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16593
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WITHHELD DETECTION AND THERAPY DURING VENTRICULAR TACHYCARDIA (VT) EPISODE FOR A PERIOD OF TIME DURING TWO EPISODES. IT WAS ALSO REPORTED THAT EVENTUALLY THE DEVICE DELIVERED TREATMENT. THEREFORE THE ONSET FEATURE WAS TURNED OFF. IT WAS LATER REPORTED THAT THE TACHY SENSE (TS) INTERVAL OF ONE OF THE EPISODES DID NOT GET RESET DUE TO THE ONSET. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLD. THE DEVICE AND RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD