BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1992366 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02794
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z0474-2011
    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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE HELIX HAD DISENGAGED FROM THE HELICAL CHANNEL. THE ANALYST ALSO NOTED THAT THE LEAD APPEARS TO HAVE BEEN IMPLANTED WITH A BEND IN IT AT THE FRACTURE SITE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THIRTEEN - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=200 MS AVERAGE V-CYCLE BETWEEN (B)(4)-2010 10:27:29 AND (B)(4)-2010 06:31:15. VENTRICULAR SHORT INTERVAL COUNT V-SIC=110.3 COUNTS AVG/DAY, IN 0.84 DAYS, BETWEEN (B)(4)-2010 13:38:49 AND (B)(4)-2010 09:52:34. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4)-2010 10:36:36.

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT TRIGGERED AND OVERSENSING WAS REPORTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT TRIGGERED AND OVERSENSING WAS REPORTED. THE LEAD WAS EXPLANTED 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 68 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB