BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951715 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00173
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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) IMPLANTABLE PULSE GENERATOR 2009 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL ELECTRODE WAS DAMAGED DUE TO PULLED/STRETCHED/OVERSTRESS, THE DISTAL ELECTRODE WAS COVERED WITH BLOOD, THE HELIX WAS DISTORTED DUE TO PULLED /STRETCHED/OVERSTRESS,THE OUTER INSULATION WAS DISTORTED DUE TO PULLED/STRETCHED/OVERSTRESS, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ATTACHED, BEATEN, AND ROBBED. HE SUFFERED A FRACTURED LEG AND TRAUMA TO HIS CHEST. APPROXIMATELY THREE WEEKS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIZZINESS AND PERIODS OF HEART RATES BELOW 60 BEATS PER MINUTE. INTERMITTENT CAPTURE WAS FOUND AND CHEST X-RAY CONFIRMED THAT THE RIGHT VENTRICULAR LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ATTACHED, BEATEN, AND ROBBED. HE SUFFERED A FRACTURED LEG AND TRAUMA TO HIS CHEST. APPROXIMATELY THREE WEEKS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIZZINESS AND PERIODS OF HEART RATES BELOW 60 BEATS PER MINUTE. INTERMITTENT CAPTURE WAS FOUND AND CHEST X-RAY CONFIRMED THAT THE RIGHT VENTRICULAR LEAD HAD DISLODGED. 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
    57233 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD