BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 3062165 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06396
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 CONTINUED: 5076-58 IMPLANTABLE PACING LEAD: (B)(6) 2006. 5076-52 IMPLANTABLE PACING LEAD: (B)(6) 2006. (B)(4).

    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 PACEMAKER SHOWED NOISE REVERSION ON STORED DIAGNOSTICS WITH POTENTIAL ELECTROMAGNETIC INTERFERENCE. THE SOURCE OF THESE NON-PHYSIOLOGIC EVENTS WAS UNDETERMINED. 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
    163870 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1