BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2051922 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05693
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS BLOOD IN. ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THERE WAS APPARENT EXPLANT DAMAGE.

    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) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS BLOOD IN. ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THERE WAS APPARENT EXPLANT DAMAGE.

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD A SUDDEN INCREASE IN PACING IMPEDANCE TO OUT OF MEASURABLE RANGE, POSSIBLY DUE TO A LEAD FRACTURE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT SHORTLY FOLLOWING THE IMPLANT, NOISE WAS SEEN ON THE ELECTROGRAM. IT WAS FURTHER NOTED THAT DURING A PROCEDURE TO CHECK FOR A LOOSE SET SCREW, THE RIGHT VENTRICULAR LEAD APPEARED TO BE PROPERLY SECURED. WHEN, DURING THIS SAME PROCEDURE, THE LEAD WAS UNCOILED, SENSING DIFFICULTIES CEASED AND THE IMPEDANCE WAS BACK IN RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD A SUDDEN INCREASE IN PACING IMPEDANCE TO OUT OF MEASURABLE RANGE POSSIBLY DUE TO A LEAD FRACTURE, AND NOISE WAS SEEN OF THE ELECTROGRAM. THE LEAD WAS REMOVED AND REPLACED. 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 SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMP PACEMAKER/CARDIO/DEFIB| (B)(4) COMPETITOR IMP PACEMAKER/CARDIO/DEFIB| (B)(4) COMPETITOR IMP PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD