BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1992081 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02715
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 30, 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
    VA, 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) NO ANOMALIES FOUND. ADDITIONAL FINDINGS OF THE OUTER INSULATIONS COSMETIC ENVIRONMENTAL STRESS CRACKING AND COSMETIC DEPRESSION. PROXIMAL SEGMENT OR LEAD RETURNED AND ANALYZED.

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT WAS TRIGGERED IN PATIENT. THE ELECTROGRAM CONFIRMED INTERMITTENT NOISE ON THE RIGHT VENTRICULAR PACE/SENSE PORTION OF THE LEAD. IT WAS ALSO REPORTED THAT THERE WAS AN INCREASE IN PACING IMPEDANCE. DURING ATTEMPTED EXPLANT THE SCREW MECHANISM SPUN FREELY WITH NO RETRACTION OF THE HELIX. THE PROXIMAL PORTION OF THE LEAD WAS CUT, CAPPED, AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT WAS TRIGGERED IN PATIENT. THE ELECTROGRAM CONFIRMED INTERMITTENT NOISE ON THE RIGHT VENTRICULAR (RV) PACE/SENSE PORTION OF THE LEAD. IT WAS ALSO REPORTED THAT THERE WAS AN APPARENT LEAD FRACTURE AND INCREASE IN PACING IMPEDANCE. DURING ATTEMPTED EXPLANT THE SCREW MECHANISM SPUN FREELY WITH NO RETRACTION OF THE HELIX. THE PROXIMAL PORTION OF THE LEAD WAS CUT, CAPPED, AND A NEW LEAD WAS IMPLANTED. 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 70 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB