BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2952585 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00625
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. PRODUCT EVENT SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE DISTAL ELECTRODE WAS COVERED IN BLOOD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE PHYSICIAN DID NOT LIKE THE ELECTROGRAM OF THE RIGHT VENTRICULAR (RV) LEAD AND WAS UNABLE TO EVALUATE THE INJURY PATTERN. THE LEAD WAS REMOVED AND REPLACED WITH A SECOND LEAD BUT A SIMILAR SIGNAL WAS OBTAINED SO THE POSITION WAS ACCEPTED. THE SECOND 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
    56953 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR