BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3152711 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06676
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/ STRETCHING/OVERSTRESS. THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL IMPLANT AND THE POSITIONING OF THE RIGHT VENTRICULAR (RV) LEAD, THE PHYSICIAN OBSERVED VIA FLUOROSCOPY THAT THE HELIX OF THE LEAD WAS EXTENDED. THE LEAD WAS TURNED TO RETRACT THE HELIX, BUT FOUND AGAIN THAT THE TIP OF THE HELIX WAS NOT MOVING. THE LEAD WAS EXTRACTED AND FOUND THAT THE HELIX WAS PERMANENTLY DAMAGED. 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
    253298 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR