BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051912 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05683
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. EVALUATION SUMMARY: (B)(4) THE MEDIAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED, THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD A COSMETIC ENVIRONMENTAL STRESS CRACK, THE OUTER OVERLAY TUBING HAD WHITE SUBSTANCE. APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REMOVED DUE TO POCKET INFECTION. IT WAS ALSO REPORTED THERE WAS POSSIBLE VEGETATION ON THE LEAD. 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 54 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD