BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 3051851 · Received April 10, 2013

    Report

    Report Number
    9614453-2013-00964
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. 5592 IMPLANTABLE PACING LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED OUTPUT BOND WIRES WHICH OCCURRED THE SAME DAY AS THE REPORTED EXPLANT DATE. (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 PATIENT EXPERIENCED SYNCOPE. THE DEVICE WAS SUSPECTED WITH A PROBLEM. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148323 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. (SMO) SSR303U

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R