BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3861269 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11231
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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: 507645, LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REQUEST REIMBURSEMENT RELATED TO HER DEVICE REPLACEMENT. THE DEVICE DID NOT MEET MATURITY OR GUARANTEE AS THE BATTERY WAS REPLACED PRIOR TO EXPECTED. THE PATIENT UNDERSTOOD THAT THE BATTERY WAS DYING AND REQUESTED REIMBURSEMENT FOR PAIN AND SUFFERING. 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
    340483 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 507652 LEAD