BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 1991162 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00248
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE HIGH CURRENT DRAIN CONDITION WAS THE RESULT OF EXCESS LEAKAGE CURRENT INTERNAL TO THE TANTALUM CAPACITOR C1.

    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. 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 PATIENT ATTENDED YEARLY FOLLOW UP CLINIC. DURING FOLLOW-UP IT WAS NOTED THAT THE PACEMAKER WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPROGRAMMING OF THE PACEMAKER PARAMETERS WAS NOT POSSIBLE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP IT WAS NOTED THAT THE PACEMAKER WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPROGRAMMING OF THE PACEMAKER PARAMETERS WAS NOT POSSIBLE. IT WAS ALSO REPORTED THAT THE DEVICE WAS ONLY IMPLANTED SINCE 2007. THE PATIENT IS SCHEDULED FOR REPLACEMENT. 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 SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R