BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3031101 · Received April 2, 2013

    Report

    Report Number
    2649622-2013-02586
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. CONCOMITANT PRODUCTS: PRODUCT ID, 5076 IMPLANTED: 2006 (B)(6); PRODUCT ID, (B)(4) IMPLANTED: 2005 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, WAS ANALYZED AND ANALYSIS REVEALED A BREACHED DEPRESSION OF THE OUTER INSULATION. IT WAS NOTED THERE WAS COSMETIC DEPRESSION OF THE OUTER INSULATION AND IT WAS OBSERVED THERE WAS BLOOD INGRESSION OF THE OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STORED ELECTROGRAMS FOR THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) PACING LEADS SHOWED EVIDENCE OF OVERSENSING NON-PHYSIOLOGIC SIGNALS AS FAST INTERVALS. BOTH RA AND RV LEADS WERE REMOVED AND REPLACED. THE LEADS HAVE BEEN RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STORED ELECTROGRAMS FOR THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) PACING LEADS SHOWED EVIDENCE OF OVERSENSING NON-PHYSIOLOGIC SIGNALS AS FAST INTERVALS. BOTH RA AND RV LEADS WERE REMOVED AND REPLACED. THE LEADS HAVE BEEN RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135204 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| R