BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921443 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12527
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE 6949 LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE 6949 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "INTERFERENCE/NOISE". VENTRICULAR SHORT INTERVAL COUNTS= 30.7 COUNTS AVG/DAY, WITHIN 0.55 DAYS ON (B)(6) 2010 IN THE TIMEFRAME BETWEEN 08:47:08 AND 22:03:30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE FOR MULTIPLE SHOCKS, AND THAT THERE IS A HISTORY OF ATRIAL LEAD SENSING DIFFICULTY DUE TO LOW AMPLITUDE, AND INTERMITTENT FAR FIELD R-WAVE OVERSENSING. INTERMITTENT OVERSENSING AND DOUBLE COUNTING OF R-WAVES AFTER SHOCKS WAS ALSO REPORTED. BOTH LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE FOR MULTIPLE SHOCKS, AND THAT THERE IS A HISTORY OF ATRIAL LEAD SENSING DIFFICULTY DUE TO LOW AMPLITUDE, AND INTERMITTENT FAR FIELD R-WAVE OVERSENSING. INTERMITTENT OVERSENSING AND DOUBLE COUNTING OF R-WAVES AFTER SHOCKS WAS ALSO REPORTED. BOTH LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO ORIGINALLY REPORTED THAT THERE WAS ATRIAL LEAD UNDERSENSING. BOTH LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB