BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1992656 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00201
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS TORN AND THE OUTER TUBING OVERLAY WAS BREACHED CUT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH PACING AND SUPERIOR VENA CAVA IMPEDANCES AND THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. IT WAS LATER REPORTED THAT THE LEAD HAD AN APPARENT FRACTURE. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4592 IMPLANTABLE PACING LEAD