BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3062157 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05111
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED. THE EXPOSED RIGHT VENTRICULAR (RV) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR. THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. HELIX EXTENSION/RETRACTION AND LENGTH TESTING COULD NOT BE PERFORMED DUE TO THE BENT HELIX. DUE TO THE LIMITED AMOUNT OF BLOOD INGRESS THROUGHOUT THE LEAD, IT IS LIKELY THAT THE DAMAGE THAT WAS OBSERVED WAS DUE TO EXPLANT DAMAGE. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS.

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHT DAYS POST IMPLANT THE RIGHT VENTRICULAR LEAD HAD UNSTABLE PACING THRESHOLDS. IT WAS DECIDED TO REPOSITION THE LEAD. HOWEVER, DURING THE LEAD REPOSITIONING PROCEDURE THE HELIX COULD NOT BE RE-EXTENDED. THE LEAD WAS REMOVED AND A NEW LEADWAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHT DAYS POST IMPLANT THE RIGHT VENTRICULAR LEAD HAD UNSTABLE PACING THRESHOLDS. IT WAS DECIDED TO REPOSITION THE LEAD. HOWEVER, DURING THE LEAD REPOSITIONING PROCEDURE THE HELIX COULD NOT BE RE-EXTENDED. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163722 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R D204DRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB