BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3051068 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04759
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE 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. CONCOMITANT MEDICAL PRODUCTS: D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: (B)(6) 2010. 4193 IMPLANTABLE PACING LEAD: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING WHICH APPEARS TO BE LEAD NOISE DUE TO LEAD FRACTURE. THE LEAD ALSO HAD A HIGH NUMBER OF SHORT V-V INTERVALS WHICH TRIGGERED A LEAD INTEGRITY ALERT (LIA) AND OCCASIONAL PACING INHIBITION DUE TO OVERSENSING. THE LEAD WAS CAPPED 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
    153625 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R 4558M IMPLANTABLE PACING LEAD