BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3153681 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06166
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    February 3, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 5592-53, IMPLANTABLE PACING LEAD: (B)(6) 2013. ADDRL1 IMPLANTABLE PULSE GENERATOR: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT 'SYMPTOMATIC' THREE DAYS POST-IMPLANT AT THE PHYSICIAN'S OFFICE. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS HAD PULLED BACK. BOTH LEADS WERE REPOSITIONED. THE PATIENT PRESENTED TO THE CLINIC 20 DAYS LATER REPORTING A 'HICCUPS' FEELING. THE PATIENT WAS REFERRED TO THE HOSPITAL WHERE PER CHEST X-RAY THE RIGHT VENTRICULAR LEAD WAS IN THE CORONARY SINUS VEIN. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256966 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R