BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791594 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14541
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED "SHARP SHOCK ON THE LEFT SIDE OF THE CHEST" FOR ABOUT A MONTH AND A HALF. THE SHOCKS OCCURRED SEVERAL TIMES PER DAY AND WERE INTERMITTENT BY DAY. THE PATIENT IS WONDERING IF THIS IS RELATED TO THE DEVICE OR LEADS. FOLLOW UP WAS ATTEMPTED TO DETERMINE IF THE ALLEGATION WAS RELATED TO THE DEVICE OR LEADS BUT WAS UNSUCCESSFUL. RECORDS INDICATE THAT THE DEVICE AND LEADS REMAIN 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
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| O