BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1554333 · Received December 9, 2009

    Report

    Report Number
    2649622-2009-03091
    Event Type
    Injury
    Date Received
    December 9, 2009
    Date of Event
    September 14, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE ICD DEVICE INDICATES THE RV PACE IMPEDANCE MEASUREMENT HAS BEEN VARIABLE THROUGHOUT THE RECORD ENDING 25 AUG 2009. THE MIN VALUE RANGED FROM 424 - 1200 OHMS AND THE MAX VALUE RANGED FROM 560 - 1568 OHMS. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 1193 AND ALL COUNTS OCCURRED SINCE 28 MAY 2008. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD VARYING IMPEDANCE, HIGH IMPEDANCE, NOISE/OVERSENSING, AND POSSIBLE FRACTURE. ALSO REPORTED WAS THAT THE LEAD WAS "VISIBLY POKING FROM WITHIN THE POCKET." A NEW RV LEAD WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB