BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ T SERIES DR

    MDR report key: 2051895 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05681
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE REPORTED TELEMETRY CONDITION COULD NOT BE CONFIRMED. TELEMETRY WAS FUNCTIONAL DURING ALL LAB TESTS. CORRECTION: INITIAL REPORT SUBMITTED ON (B)(6) 2011 REFLECTED THE INCORRECT MANUFACTURING SITE. THEREFORE A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INDICATE THE CORRECT MANUFACTURING SITE AS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED. THE IPG WAS SET AT A MAGNET RATE OF ONE HUNDRED BEATS PER MINUTE. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ T SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. T70A1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R