BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072913 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03666
    Date Received
    July 10, 2008
    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
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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) NO ANOMALIES FOUND; FULL LEAD ANALYZED. EVALUATION SUMMARY: (B)(4) THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED AND ANALYZED. ANALYSIS FINDINGS DEMONSTRATED GROMMET DAMAGE. THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO GROMMET PUNCH-OUT WITH BLOCKING (DRIVEN BY SELF-ADHESION BETWEEN GROMMET HALVES OVER TIME) OR GROMMET PUNCH-OUT WITHOUT BLOCKING (DRIVEN BY WRENCH FRICTION AND LOW SILICONE STIFFNESS). CONSEQUENTLY, CORRECTIVE ACTIONS ((B)(4)) HAVE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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: NO ANOMALIES FOUND; FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED DUE TO NOISE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| C174AWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB