BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1791394 · Received August 10, 2010

    Report

    Report Number
    6000094-2010-01443
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    January 28, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. THE EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED AN ERI (ELECTIVE REPLACEMENT INDICATOR) CONDITION. ANALYSIS OF THE MEMORY DUMP REVEALED ANOMALOUS BATTERY VOLTAGE MEASUREMENTS CAUSED BY A MEASUREMENT LOCK-UP, RESULTING IN AN UNCLEARABLE ERI. THE CONDITION WAS THE RESULT OF A TIMING ANOMALY INTERNAL TO THE PACING/SENSING INTEGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP, WHERE THE DEVICE WAS FOUND TO BE AT ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other