BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3992119 · Received August 8, 2014

    Report

    Report Number
    2647346-2014-00072
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: 1488T COMPETITOR LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 PATIENT PRESENTED TO THE EMERGENCY ROOM, WHERE THE DEVICE WAS NOTED TO BE AT EOL (END OF LIFE). FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION. 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
    469592 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL E2DR03AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 1488T COMPETITOR LEAD