BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2953494 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01157
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION WAS BREACHED/CUT. CONCOMITANT PRODUCTS 4076 IMPLANTABLE PACING LEAD - (B)(6) 2012, 4296 IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE OF MONTHS, THE PATIENT EXPERIENCED THREE HEMATOMAS, ALL OF WHICH WERE EVACUATED. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE PROTRUDING THROUGH THE SKIN NEAR THE POCKET. THE SYSTEM WAS EXPLANTED, AND WILL BEREPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE OF MONTHS, THE PATIENT EXPERIENCED THREE HEMATOMAS, ALL OF WHICH WERE EVACUATED. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE PROTRUDING THROUGH THE SKIN NEAR THE POCKET. THE SYSTEM WAS EXPLANTED, AND WILL BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56474 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R (B)(4) IMPLANTABLE DEFIBRILLATOR