BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921644 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12626
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 8, 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
    SC, 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD HAS BEEN STRETCHED CAUSING THE INNER TUBING TO BUCKLE. THIS PREVENTS PROPER TORQUE TRANSFER WHEN TURNING THE IS-1 PIN. IT WAS NOTED THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM. LEAD DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAPTURE THRESHOLD HAD INCREASED. IT WAS NOTED THE PATIENT HAS COMPLETE HEART BLOCK. THE LEAD WAS REMOVED AND REPLACED. ON THE INITIAL ATTEMPT TO REPLACED THE LEAD THE PHYSICIAN WAS HAVING DIFFICULTY PASSING THE LEAD THROUGH THE INTRODUCER AS THE PATIENT HAD A VERY TORTUOUS ACCESS. AFTER USING MULTIPLE STYLETS WHICH KEPT KINKING THE PHYSICIAN REMOVED THE LEAD AND NOTICED THE HELIX WOULD NOT RETRACT. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 31 YR Hospitalization| O| R 7950U IMPLANTABLE PULSE GENERATOR| 4269 COMPETITOR IMPLANTABLE PACING LEAD