BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2200590 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11017
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    NH, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THE DISTAL CONDUCTOR STRETCHED, THE OUTER INSULATION PULLED APART (OVERSTRESS), THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON HELIX/LOBE MECHANISM, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS BLOOD IN/ON HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS UNDERSENSING, THERE WAS NO EVIDENCE OF ATRIAL CAPTURE, THE MARKERS FOR THE ATRIAL SENSES DID NOT CORRESPOND TO THE P-WAVES SEEN ON THE ELECTROGRAM, AND THE PATIENT WAS SYMPTOMATIC WITH FATIGUE. IN ADDITION, IT WAS NOTED THAT THIS WAS DUE TO LEAD ISOLATION RELATED TO AN ATRIAL ABLATION PROCEDURE THAT THE PATIENT UNDERWENT. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT A SYSTEM INFECTION WAS REPORTED AND ALL LEADS WERE EXPLANTED AND NOT REPLACED. NO FURTHER 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 44 YR Hospitalization| R 148674 COMPETITOR IMPLANTABLE PULSE GENERATOR| 7496 IMPLANTABLE NEURO EXTENSION| 3987 IMPLANTABLE PAIN STIMULATION LEAD| 7425 IMPLANTABLE PAIN STIMULATOR