BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2813282 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16994
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND NO ANOMALIES. IT WAS NOTED THAT THERE WAS OVERSENSING EMI/NOISE WITH 324 NON-PHYSIOLOGICAL SENSING COUNTS. THE ANALYST COMMENTED THAT THE 324 NON-PHYSIOLOGICAL COUNTS WOULD NOT BE SUFFICIENT TO TRIGGER A LEAD WARNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ELECTROGRAM SHOWED THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD INTERMITTENT NOISE ON SEVERAL HIGH RATE EPISODES. IT WAS NOTED THAT BOTH LEADS WERE PROGRAMMED TO UNIPOLAR SENSING. ALSO, THERE WAS A LEAD WARNING FOR THE RV LEAD HAVING LOW IMPEDANCE WHICH HAD BEEN CHRONICALLY LOW IN THE LOW 200 OHMS RANGE. THE RA AND RV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DTB MEDTRONIC PUERTO RICO, INC. 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other ADDR01 IMPLANTABLE PULSE GENERATOR