BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2965236 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02214
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: 3830 IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    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: 3830 IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE PACEMAKER DIAGNOSTIC PLOT AND QUICK LOOK REPORT INCONSISTENTLY DISPLAYED THE DATE THE THRESHOLD WAS LAST TAKEN. IT WAS FURTHER NOTED THE DATE OF THE CLINICAL STATUS SUMMARY WAS THE SAME DAY, WHEN IT WAS THOUGHT TO BE A LONGER PERIOD. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67366 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MPRI ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 3830 IMPLANTABLE PACING LEAD