BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3152491 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06773
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 4196 IMPLANTABLE PACING LEAD (B)(6) 2013; ADSR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2009; 4023 IMPLANTABLE PACING LEAD (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED CAUSING LOSS OF CAPTURE. 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
    253123 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I