BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR PACEMAKER

    MDR report key: 2952466 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01722
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT HAD SURGERY AND AFTER THE SURGERY, THE DOCTOR STATED THAT THE DEVICE WAS NOT WORKING RIGHT. FOLLOW UP WAS CONDUCTED AND NO ADDITIONAL INFORMATION WAS AVAILABLE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55859 ADAPTA DR PACEMAKER PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR 4076 NON-DEFIB LEAD