BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 1871923 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17428
    Date Received
    October 16, 2010
    Report Date
    September 16, 2010
    Product Code
    NVN
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH THE HELIX EXTENDED. THERE WAS DRIED BLOOD FOUND THROUGH OUT THE LUMEN. THE CATHODE COILS ARE FRACTURED DISTAL OF THE SUTURE TIE DOWN AT 230 MM AND PROXIMAL OF THE ABRASION AT 234 MM FROM THE TERMINAL PIN. THERE WAS ALSO EVIDENCE OF CLAVICLE ABRASION AT 238 - 252 AND AT 234 - 254 MM FROM THE TERMINAL PIN. THE INSULATION WAS FOUND TO BE STRETCHED BETWEEN THE HELIX HOUSING AND ANODE RING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. THE PHYSICIAN WENT IN TO EXPLANT THE LEAD AND IT WAS FOUND TO BE FRACTURED. THE PATIENT DID SUFFER A PREVIOUS NON DEVICE RELATED FALL, AND THAT WAS THOUGHT TO HAVE CONTRIBUTED TO THE FRACTURE. THERE WERE SEVERAL INAPPROPRIATE MODE SWITCHES FOUND IN THE ARRHYTHMIA LOGBOOK AS WELL. THE DEVICE WAS EXPLANTED AT THE SAME TIME TO AVOID ANY FUTURE ADDITIONAL SURGERIES FOR THIS PATIENT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. THE PHYSICIAN WENT IN TO EXPLANT THE LEAD AND IT WAS FOUND TO BE FRACTURED. THE PATIENT DID SUFFER A PREVIOUS NON DEVICE RELATED FALL, AND THAT WAS THOUGHT TO HAVE CONTRIBUTED TO THE FRACTURE. THERE WERE SEVERAL INAPPROPRIATE MODE SWITCHES FOUND IN THE ARRHYTHMIA LOGBOOK AS WELL. THE DEVICE WAS EXPLANTED AT THE SAME TIME TO AVOID ANY FUTURE ADDITIONAL SURGERIES FOR THIS PATIENT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE LEAD NVN

    Patients

    Seq Age Sex Outcome Treatment
    1 1298| 4088| 4087