BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2964646 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02119
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 31, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF PERFORMANCE DATA FOUND OVERSENSING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT PRODUCT ANALYSIS FOUND THAT THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. EVALUATION SUMMARY: THE 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE AND AN APPARENT LEAD FRACTURE. IT WAS NOTED ON X-RAY THAT THE LEAD WAS APPARENTLY TWISTED AROUND AN OLD, ABANDONED TACHY LEAD, WITH LIMITED SEPARATION BETWEEN THE VARIOUS ELECTRODES. 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
    67308 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5076 IMPLANTABLE PACING LEAD