BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4103775 · Received September 19, 2014

    Report

    Report Number
    2649622-2014-10363
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV LEAD HAD DISPLAYED T WAVE OVERSENSING AND NOISE. THE PRODUCT HAS BEEN RETURNED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO NON-SUSTAINED EPISODES AND HIGH IMPEDANCE >3,000 OHMS WITH THE RIGHT VENTRICULAR (RV) LEAD. IN THE PAST 8 DAYS IMPEDANCE HAS FLUCTUATED BETWEEN 350-950 OHMS. OVERSENSING WAS OBSERVED AND APPEARED TO BE NONPHYSIOLOGIC ON BOTH TIP TO RING AND TIP TO COIL ELECTROGRAMS. TECHNICAL SERVICES DISCUSSED FURTHER TESTING RECOMMENDATIONS AND TO CONSIDER LEAD REPLACEMENT IF LEAD COMPROMISE IS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS SUBSEQUENTLY EXPLANTED AND APPEARED TO BE FRACTURED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582640 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization| R D314VRG ICD