BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 1913308 · Received December 3, 2010

    Report

    Report Number
    2649622-2010-12198
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    August 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWED BATTERY GOOD - 2.1 OHMS WITH ESTIMATED LONGEVITY OF 0.5 TO 1 YEAR. A MONTH AND A HALF LATER, FOLLOW-UP REVEALED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR 3 WEEKS EARLIER. THE DEVICE IS PLANNED TO BE REPLACED WITHIN THE NEXT 2 WEEKS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC PUERTO RICO, INC. C60A2 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R