BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153568 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06101
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL IMPLANT, THE PHYSICIAN INSERTED THE LEAD INTO THE RIGHT VENTRICULAR APEX. DURING MAPPING TO FIND THE BEST POSITIONING, THE PHYSICIAN FELT THAT THE LEAD WAS NOT ACHIEVING THE SENSING MEASUREMENTS THAT WERE NECESSARY. THE PHYSICIAN FELT THAT THERE WAS SOMETHING WRONG WITH THE LEAD THAT WAS CAUSING POOR POSITIONING VALUES. THE RV LEAD WAS NOT USED AND A DIFFERENT LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257046 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR