BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2812983 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17205
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THERE WAS BLOOD (NOT OBSTRUCTED) ON THE DISTAL AND PROXIMAL CONDUCTOR OF THE LEAD. THERE WAS AN OUTER INSULATION BREACH/CUT. THE PROXIMAL CONDUCTOR OF THE LEAD WAS DISTORTED, KINKED/BUCKLED. VISUAL ANALYSIS REVEALED THERE WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED A DAY AFTER IMPLANT. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. DURING REPLACEMENT WITH THE NEW THE LEAD THE LEAD WAS UNABLE TO FIXATE TO THE VEIN DUE TO THE LOBES NOT DEPLOYING SUCCESSFULLY. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED A DAY AFTER IMPLANT. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. DURING REPLACEMENT OF THE NEW LEAD THE PHYSICIAN WAS UNABLE TO FIXATE TO THE VEIN DUE TO THE LOBES NOT DEPLOYING SUCCESSFULLY. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO 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 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD