BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 2953724 · Received February 9, 2013

    Report

    Report Number
    2647346-2013-00013
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 PRODUCT: 4076 NON-DEFIB LEAD: (B)(6) 2004; 5032 NON-DEFIB LEAD: (B)(6) 1998. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NON-RESPONSIVE TO THE MAGNET APPLICATION AND UNABLE TO BE INTERROGATED WITH PROGRAMMER. THE DEVICE APPEARED TO BE AT END OF LIFE (EOL). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NON-RESPONSIVE TO THE MAGNET APPLICATION AND UNABLE TO BE INTERROGATED WITH PROGRAMMER. THE DEVICE APPEARED TO BE AT END OF LIFE (EOL). 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
    57290 ENPULSE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 4471 COMPETITOR NON-DEFIB LEAD