BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLENCE PS+

    MDR report key: 1922394 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12906
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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): NO ANOMALIES FOUND, HOWEVER THERE WAS OUTER INSULATION COSMETIC DEPRESSION AND BLOOD NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED); PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, HOWEVER THERE WAS OUTER INSULATION COSMETIC DEPRESSION, OUTER INSULATION PULLED APART (OVERSTRESS), APPARENT EXPLANT DAMAGED NOTED, AND BLOOD NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED); FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ATRIAL AND VENTRICULAR LEADS WERE FOUND TO BE "DYSFUNCTIONAL IN SENSING AND PACING". THE LEADS WERE ABANDONED AND NEW LEADS WERE IMPLANATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELLENCE PS+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMK49B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R