BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2955376 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01374
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    February 16, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE.

    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 WITHIN A COUPLE DAYS OF IMPLANT, THE PATIENT WAS EXPERIENCING PROLONGED PAUSES, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE AND WAS FOUND TO HAVE DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO TIGHTEN THE RV SETSCREW ON THE EXISTING DEVICE. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED AS WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE DAYS OF IMPLANT, THE PATIENT WAS EXPERIENCING PROLONGED PAUSES, AND THE RIGHT VENTRICULAR (RV)LEAD EXHIBITED A LOSS OF CAPTURE AND WAS FOUND TO HAVE DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO TIGHTEN THE RV SETSCREW ON THE EXISTING DEVICE. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED AS WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58003 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER