BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1874625 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11471
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATES A LOW RESISTANCE/IMPEDANCE, IMPEDANCE/RESISTANCE DECREASE CONDITION ON THE LEAD. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARDIAC LEAD IMPEDANCE WAS TRENDING DOWNWARD, RECENTLY MEASURED AT 212 OHMS AND THAT THE PATIENT STATED THE DEVICE WAS BEEPING. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES, WITH NO KNOWN REASON WHY. THE LEAD WAS ALSO REPORTED AS FAILED. THE LEAD WAS CAPPED AND REPLACED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARDIAC LEAD IMPEDANCE WAS TRENDING DOWNWARD, RECENTLY MEASURED AT 212 OHMS AND THAT THE PATIENT STATED THE DEVICE WAS BEEPING. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES, WITH NO KNOWN REASON WHY. THE LEAD WAS ALSO REPORTED AS FAILED. THE LEAD WAS CAPPED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1582 COMPETITOR IMPLANTABLE TACHY LEAD| 4068 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 1582 COMPETITOR IMPLANTABLE TACHY LEAD| 4068 IMPLANTABLE PACING LEAD