BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2952199 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00100
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    August 29, 2012
    Report Date
    November 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED THAT THE DEVICE BEHAVIOR WAS THE RESULT OF A LOOSE/DETACHED EMA WIREBOND. CONCOMITANT MEDICAL DEVICE: 5054 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2003 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHECK THE IMPLANTABLE PULSE GENERATOR (IPG) SHOWED LEAD IMPEDANCES OVER 9999 OHMS AND PACING FAILURE WAS OBSERVED AT HIGH OUTPUTS. DURING THE DEVICE CHANGE OUT THE LEADS WERE TESTED THROUGH THE ANALYZER AND ALL VALUES WERE NORMAL, THEREFORE ABNORMALITY OF THE IPG WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55681 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SDR303

    Patients

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