BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1991146 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02270
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED) AND IN/ON THE HELIX MECHANISM. THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR TACHY LEAD HAD IMPEDANCE VARIATIONS AND HIGH THRESHOLDS. THE PACE/SENSE PORTION OF THE LEAD WAS ABANDONED AND REPLACED. OVERSENSING AND NOISE WERE DETECTED WHEN THE NEWLY IMPLANTED PACE/SENSE LEAD WAS CONNECTED TO THE DEVICE. CONNECTOR PROBLEMS WERE SUSPECTED WITH THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. THE OVERSENSING AND NOISE CONTINUED. THE NEWLY IMPLANTED PACE/SENSE LEAD WAS EXPLANTED AND REPLACED. THE OVERSENSING AND NOISE WAS RESOLVED. THE HIGH VOLTAGE PORTION OF THE RIGHT VENTRICULAR TACHY LEAD IS STILL IN USE. NO 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 PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R