BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3152310 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01566
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 29, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. A 419388 IMPLANTABLE PACING LEAD, (B)(6) 2002. A 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A SHOCK WHILE WORKING ON A VEHICLE MOTOR, AND THAT THE HIGH VOLTAGE COIL IMPEDANCES HAD VARIED. THE LEAD WAS LATER EXPLANTED AND REPLACED DUE TO MEDICAL JUDGEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A SHOCK WHILE WORKING ON A VEHICLE MOTOR, AND THAT THE HIGH VOLTAGE COIL IMPEDANCES HAD VARIED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252885 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Life Threatening (B)(4) IMPLANTABLE CRT-D