BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922150 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12775
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS STRETCHED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THERE WAS A TIP SEAL OBSERVATION, THERE WAS A SHAFT SEAL OBSERVATION, THE LEAD APPEARED DAMAGE AT IMPLANT AND THE LEAD WAS STRETCHED. IT WAS ALSO NOTED THAT THE LEAD WAS RETURNED WITH THE STYLET STUCK IN THE LEAD AND THE DISTAL COIL STRETCHED AT THE DISTAL END OF THE LEAD. IT IS NOT POSSIBLE TO TEST THE HELIX IF THE LEAD IS RETURNED IN THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD POSITIONING/FIXATION DIFFICULTY AND PERFORATED THE HEART. THE HELIX WOULD NOT EXTEND AFTER THE INITIAL EXTENDING/RETRACTING. THE LEAD WAS NOT IMPLANTED AND A NEW LEAD WAS USED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R