BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2952748 · Received February 9, 2013

    Report

    Report Number
    3008973940-2013-00011
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. CONCOMITANT MEDICAL PRODUCT: 5054, IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT PROCEDURE, NOISE APPEARED ON THE ELECTROGRAM. THE LEADS WERE DISCONNECTED AND RECONNECTED, BUT THE NOISE PERSISTED. THE DEVICE WAS REMOVED AND REPLACED. A SECOND DEVICE WAS IMPLANTED AND REMAINS IN USE; HOWEVER, THE NOISE IS STILL PRESENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55910 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR 5554 IMPLANTABLE PACING LEAD