BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953765 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01247
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2001 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE V-LEAD (VENTRICULAR-LEAD) PERFORMANCE DIAGNOSTICS WERE CLEARED. LIMITED STORED DATA ((IMPEDANCE TREND AND VCM (VENTRICULAR CAPTURE MANAGEMENT)) AVAILABLE DID NOT INDICATE LEAD ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE DUE TO LOSS OF CAPTURE OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED A FIFTEEN SECOND PAUSE AND CONVULSIONS, AND THAT THE PATIENT HAD VARYING ESCAPE RHYTHMS WHICH WERE MOSTLY IN THE THIRTY'S. IT WAS ALSO REPORTED THAT THE RV LEAD HAD INTERMITTENT CAPTURE IN BOTH UNIPOLAR AND BIPOLAR. AT FIRST IT WAS POSITIONAL,THE LEAD WOULD CAPTURE WHEN LYING DOWN AND FAILED TO CAPTURE WHEN SITTING UP, THEN IT BECAME VERY UNPREDICTABLE. THE LEAD HAD HIGH IMPEDANCE IN UNIPOLAR AND IT WAS NOTED THAT THERE WAS A POLARITY SWITCH THAT HAD OCCURRED. THE LEAD WAS ALSO SUSPECT OF A POTENTIAL FRACTURE DUE TO INTERMITTENT CAPTURE. DURING THE PROCEDURE THE RV LEAD WAS TESTED THRU THE ANALYZER AND CONFIRMED NO CAPTURE AND HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57441 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR