BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2952924 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01831
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS INTERROGATED THAT A POP UP MESSAGE WITH THE DIAGNOSTICS APPEARED THAT STATED "DIAGNOSTICS MAY NOT MATCH PROGRAMMED PARAMETERS SINCE LAST DIAGNOSTIC PARAMETER" KEPT APPEARING. IT WAS NOTED THAT ALL THE DIAGNOSTICS LOOKED REAL AND PHYSIOLOGICAL AND THAT NO REPROGRAMMING HAD BEEN DONE. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN ADMITTED FOR SYNCOPE BUT THERE DID NOT APPEAR TO BE ANYTHING WITH THE DEVICE TO POINT TO A REASON FOR THE SYNCOPE. THE DEVICE IS STILL 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
    56147 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00097 YR 4574 IMPLANTABLE PACING LEAD