BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2791150 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15412
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE INNER INSULATION WAS BREACHED FROM ABRASION. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE DISTAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED) AND THE PROXIMAL CONDUCTOR WAS DISTORTED. THE ANALYST COMMENTED THAT IT CANNOT BE DETERMINED EXACTLY WHEN OR HOW THE PROXIMAL CONDUCTOR WAS DISTORTED AT 22.5 CENTIMETERS, WHERE THE INSULATION BREACH OCCURRED. DUE TO THE RESULTS OF THE SAVE TO DISK ANALYSIS AND THE OBSERVED BREACH, IT IS ASSUMED THIS HAPPENED AT IMPLANT OR IN-VIVO, NOT AT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD LOW IMPEDANCE, NO THRESHOLD AND NO CAPTURE. IT WAS NOTED THAT AT THE SITE OF THE SLEEVE IT WAS VISUALLY FOUND THAT THERE WAS CONSTRICTION AT THE LEAD. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) BATTERY VOLTAGE WAS LOWER THAN EXPECTED AFTER NINE MONTHS OF USE. THE LV LEAD AND ICD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTB MEDTRONIC PUERTO RICO, INC. 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R