BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955573 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01500
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCT: 4076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC AFTER HEARING THEIR DEVICE BEEPING. THE CLINIC HAD THE PATIENT DO A TRANSMISSION AND IT WAS FOUND THAT THE LEAD INTEGRITY ALERT HAD TRIGGERED DUE TO THE RIGHT VENTRICULAR (RV) LEAD OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT A NIPS (NON-INVASIVE PROGRAM STIMULATION) PROCEDURE WAS PERFORMED ON THE PATIENT. NO PROGRAMMING INTERVENTION WAS THEN NEEDED FOR THE RV LEAD UPON COMPLETION OF THE NIPS PROCEDURE. THE LEAD CONTINUES TO REMAIN IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58939 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB