BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951721 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00190
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ANALYZED; ANALYSIS REVEALED THE HELIX WAS DISTORTED/BENT. THERE WAS BLOOD ON THE DISTAL ELECTRODE AND THE LEAD WAS DAMAGED AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD HELIX DID NOT APPEAR TO BE EXTENDED UNDER FLUOROSCOPY. THE LEAD WAS REMOVED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57276 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR 5076 IMPLANTABLE PACING LEAD