BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1992711 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02997
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    April 26, 2010
    Report Date
    March 15, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S46
    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
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED A CONCERN REGARDING THE INTEGRITY OF THE LEAD. IMPEDANCE WAS STABLE AT APPROXIMATELY 500 OHMS, THERE WERE TWO NON-SUSTAINED TACHYCARDIAS, AND SENSING INTEGRITY COUNTER REGISTERED 71. HOWEVER, FINE BASELINE NOISE ON VTIP-VRING ELECTROGRAM WAS INDICATED IN THE MORNING AND LATE NIGHT ON TWO DIFFERENT DATES. IT WAS FURTHER REPORTED THAT THERE WERE TWO ADDITIONAL EPISODES OF OVERSENSING. IT WAS FURTHER REPORTED THAT THERE WERE 75 SHORT INTERVALS SINCE AUGUST, ALONG WITH TWO EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA. IT WAS ALSO REPORTED THAT THE PATIENT COLLAPSED WHEN THE EPISODES WERE RECORDED, BUT THAT DEVICE MALFUNCTION WAS RULED OUT PER THE ELECTROPHYSIOLOGIST. REVIEW OF DEVICE DATA SHOWED LOW AMPLITUDE NOISE ON THE ATRIAL LEAD DURING THE EPISODES WHICH DID NOT PRODUCE OVERSENSING. THE LEADS REMAIN 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 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5594 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Life Threatening| O (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB.| 4195 IMPLANTABLE PACING LEAD.| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4195 IMPLANTABLE PACING LEAD