BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 3994257 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-02005
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2008
    Report Date
    June 17, 2008
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(4). THIS DEVICE WAS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO EPISODES OF LOSS OF CONSCIOUSNESS. UPON EVALUATION IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS LOOSE AND A LOOSE SETSCREW ON THE DEVICE HEADER WAS OBSERVED. THE SETSCREW WAS TIGHTENED AND THE DEVICE REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE PROTECT PACE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466715 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R 383069 LEAD