BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1924090 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13387
    Event Type
    Injury
    Date Received
    December 14, 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): NO ANOMALIES WERE FOUND, HOWEVER, THE OUTER INSULATION HAD A COSMETIC CUT, THE LEAD WAS STRETCHED, APPARENT EXPLANT DAMAGE WAS NOTED, AND BLOOD WAS NOTED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE HELIX MECHANISM, AND THE HELIX MECHANISM (SLEEVEHEAD); THE ANALYST NOTED THAT THE HELIX WILL NOT EXTEND AT THIS TIME DUE TO DRIED BLOOD IN THE TIP END OF THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED; THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD PERFORATION AND TWO LEAD DISLODGEMENTS. IT WAS ALSO REPORTED THAT THERE WERE HIGH THRESHOLDS AND NO CAPTURE. IT WAS QUESTIONED IF THE LEAD WAS FAULTY. THE LEAD WAS EXPLANTED AND REPLACED. 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 89 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR