BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964371 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01359
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 11, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT AND THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. ON INTERROGATION THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE FRACTURED AND THE PATIENT WAS SENT HOME WITH A LIFE VEST UNTIL THE LEAD COULD BE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ON INTERROGATION IT WAS OBSERVED THAT THE ALERT TRIGGERED FOR NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND SHORT INTERVAL COUNTS (SIC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68817 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR