BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3994262 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14928
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    November 11, 2009
    Report Date
    November 17, 2009
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THIS DEVICE WAS INCLUDED IN A FIELD ACTION AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING "UNEXPLAINED BLACKOUTS" AND "MOVING OF THE PACEMAKER"; THIS WAS NOTED IN THE PATIENT'S CHART. FOLLOW-UP WITH THE DEVICE CLINIC CLARIFIED THAT THE DEVICE HAD MOVED LATERALLY TO UNDER THE PATIENT'S ARMPIT AND WAS CAUSING DISCOMFORT. THE PATIENT WAS HAVING SYNCOPAL EPISODES HOWEVER THEY WERE UNRELATED TO THE PACING SYSTEM. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468289 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR21

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| R 4076-45 LEAD, 4076-52 LEAD