BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2130802 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10253
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4). THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WERE ANALYZED. THE PATIENT ALERT TRIGGERED ON (B)(6) 2011 FOR IMPEDANCE GREATER THAN 3000 OHMS. THE WEEKLY PACE LEAD IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE IN THE MAXIMUM VENTRICULAR PACING FROM 696 TO 3184 OHMS PEAK BETWEEN (B)(6) 2011. THERE WERE THREE VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 200 MS. ON AVERAGE FOR THE VENTRICULAR CYCLE BETWEEN (B)(6) 2011. THE VENTRICULAR SHORT INTERVAL COUNT WAS 35.0 COUNTS ON AVERAGE PER DAY FOR 8.93 DAYS BETWEEN (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIPPED DUE TO HIGH IMPEDANCE OF THE RIGHT VENTRICULAR LEAD. OVERSENSING AND ABNORMAL LEAD IMPEDANCE FLUCTUATIONS WERE ALSO OBSERVED. A POTENTIAL LEAD FRACTURE WAS SUSPECTED. DURING REVISION OF THE LEAD, THE LEAD WAS DIFFICULT TO EXTRACT AND WAS PARTIALLY REMOVED, CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD FAILED TO CAPTURE. THIS LEAD WAS DIFFICULT TO EXTRACT AND WAS PARTIALLY REMOVED, CAPPED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIPPED DUE TO HIGH IMPEDANCE OF THE RIGHT VENTRICULAR LEAD. OVERSENSING AND ABNORMAL LEAD IMPEDANCE FLUCTUATIONS WERE ALSO OBSERVED. A POTENTIAL LEAD FRACTURE WAS SUSPECTED. DURING REVISION OF THE LEAD, THE LEAD WAS DIFFICULT TO EXTRACT AND WAS PARTIALLY REMOVED, CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD FAILED TO CAPTURE. THE LEAD WAS DIFFICULT TO EXTRACT AND WAS PARTIALLY REMOVED, CAPPED AND NOT REPLACED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB