BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1854828 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09307
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 18, 2010
    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
    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 FOUND; THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. THE PROXIMAL CONDUCTOR WAS FOUND DISTORTED AND BLOOD/BODY FLUID WAS OBSERVED ON ALL CONDUCTORS (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT AND HAD COSMETIC DEPRESSION; APPARENT EXPLANT DAMAGE.

    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 ATRIAL LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDENCE AND OVERSENSING, WHICH LED TO INAPPROPRIATE MODE SWITCHING. IT WAS FURTHER REPORTED THE ATRIAL LEAD WAS FRACTURED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. DURING THE ATRIAL LEAD EXTRACTION THE LEFT VENTRICULAR (LV) LEAD WAS CUT AND DISLODGED. THE LV LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE 4196 LEAD WAS USED TO REPLACE THE LV LEAD HOWEVER IT DISLODGED AND THE PATIENT WAS CRASHING SO THE PHYSICIAN DID NOT IMPLANT THE 4196 LEAD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDENCE AND OVERSENSING, WHICH LED TO INAPPROPRIATE MODE SWITCHING. IT WAS FURTHER REPORTED THE ATRIAL LEAD WAS FRACTURED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. DURING THE ATRIAL LEAD EXTRACTION THE LV LEAD WAS CUT AND DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW ASKU DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD