BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1925649 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13975
    Event Type
    Injury
    Date Received
    December 14, 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
    AU
    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 LEAD WAS PARTIALLY RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    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 DURING ROUTINE FOLLOW UP, THE PATIENT ALERT SHOWED A HIGH RIGHT VENTRICULAR (RV) IMPEDANCE (>200 OHM). DAILY OPTIVOL IMPEDANCE MEASUREMENTS SHOWED SIGNIFICANT DEVIATIONS AND MECHANICAL STRESS AT THE PATIENTS ICD POCKET SHOWED ARTEFACTS IN THE SENSING CHANNEL. RV FRACTURE IS SUSPECTED. 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 DURING ROUTINE FOLLOW UP, THE PATIENT ALERT SHOWED A HIGH RIGHT VENTRICULAR (RV) IMPEDANCE (>200 OHM). DAILY OPTIVOL IMPEDANCE MEASUREMENTS SHOWED SIGNIFICANT DEVIATIONS AND MECHANICAL STRESS AT THE PATIENTS ICD POCKET SHOWED ARTIFACTS IN THE SENSING CHANNEL. RV LEAD COIL FRACTURE IS SUSPECTED. THE LEAD WAS PARTIALLY 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

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