BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922233 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12815
    Event Type
    Injury
    Date Received
    December 13, 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
    HI, 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 DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED AN OUTER INSULATION BREACHED DEPRESSION WAS PRESENT. BLOOD/BODY FLUID WAS PRESENT ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX MECHANISM. IN ADDITION, IT WAS NOTED THAT THE DEFIB CONDUCTOR WAS DISTORTED, THE OUTER TUBING OVERLAY WAS MELTED, AND THE OUTER INSULATION WAS BREACHED CUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD AN APPARENT FRACTURE AND THAT THE LEAD INTEGRITY ALERT TRIGGERED. THE LEAD WAS EXPLANTED AND REPLACED. NO 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 67 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD