BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1921710 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12659
    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
    TX, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) A PARTIAL LEAD WAS RECEIVED IN SEGMENTS FOR ANALYSIS. THE DEFIBRILLATOR CONDUCTOR WAS FRACTURED, AND WAS DISTORTED. SEVERAL CONDUCTORS WERE FOUND WITH BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION WAS TORN, AND EXHIBITED COSMETIC DEPRESSION. THE OUTER TUBING OVERLAY BREACHED CUT. BLOOD WAS SEEN IN/ON THE HELIX/LOBE MECHANISM AND MECHANISM (SLEEVE HEAD). THERE WAS A TIP SEAL OBSERVATION. THE LEAD WAS STRETCHED. (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS OUT OF RANGE. THE LEAD WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND IT WAS CAPPED AND REPLACED AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS OUT OF RANGE. THE LEAD WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND IT WAS CAPPED AND REPLACED AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE DEVICE LONGEVITY WAS LESS THAN EXPECTED FOR THE PROGRAMMED VALUES. IT WAS ALSO NOTED THE DEVICE HAD HIGH OUTPUTS.

    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 47 YR Hospitalization| R 5071 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB