BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2131842 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10571
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DEVICE WAS RETURNED AND ANALYZED. THE DEVICE DID NOT MEET EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR WAS FRACTURED. THE DEFIBRILLATION COIL AND PROXIMAL CONDUCTOR WAS ALSO FRACTURED. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED AND THERE WAS BLOOD/BODY FLUID PRESENT ON SEVERAL CONDUCTORS (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT. THE OUTER INSULATION WAS TORN AND THERE WAS A WHITE SUBSTANCE PRESENT. BLOOD WAS ALSO FOUND IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EPISODE OF NON-PHYSIOLOGIC SENSING RESULTING IN INAPPROPRIATE SHOCKS. THE DEVICE ONLY DELIVERED PARTIAL THERAPY FOR ALL OF THE SHOCKS DESPITE CHARGING TO 35 JOULES. THERE WAS HIGH SHOCK IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCES FOR NEARLY A YEAR. THE LEFT VENTRICULAR LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE FOR THE SAME TIME. THE RV LEAD ALSO HAD OVERSENSING AND SUPPLIED INAPPROPRIATE SHOCKS. THE RV 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 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R 1488T COMPETITOR IMPLANTABLE PACING LEAD| 1488T COMPETITOR IMPLANTABLE PACING LEAD| 1488T COMPETITOR IMPLANTABLE PACING LEAD