BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2052970 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05719
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FEELS "AN ELECTRIC WAVE" THAT RADIATES FROM THE PATIENT'S ARM TO THE PATIENT'S FINGERS. IT WAS ALSO REPORTED THAT THE PATIENT STATED "I FEEL TINGLING IN MY HANDS, ARMS, AND SHOULDERS." THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FEELS "AN ELECTRIC WAVE" THAT RADIATES FROM THE PATIENT'S ARM TO THE PATIENT'S FINGERS. IT WAS ALSO REPORTED THAT THE PATIENT STATED "I FEEL TINGLING IN MY HANDS, ARMS, AND SHOULDERS." IT WAS ADDITIONALLY REPORTED THAT THE PATIENT STATED "I FEEL ELECTRICITY RUNNING THROUGH MY BODY." THE PATIENT FEELS THIS SENSATION IN ARMS, LEGS, STOMACH, HANDS, AND ESPECIALLY IN THE RIGHT SHOULDER BY THE DEVICE. THE PATIENT REPORTED TO HIS DOCTOR AND THE DEVICE CHECK TURNED OUT OK. THE LEAD REMAINS IN USE. THE PATIENT FURTHER REPORTED EXPERIENCING "ELECTRICAL FEELING IN CHEST AREA AND IN ARM" AND ALSO STATED "I HAVE HEADACHES AND FLUID RETENTION." THE DEVICE CHECK WAS OK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB