BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1925688 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14004
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 5, 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
    AL, 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) UPON ANALYSIS IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND, THERE WAS BLOOD/FLUID ON THE DISTAL CONDUCTOR (NON-OBSTRUCTING), THERE WAS BLOOD/FLUID ON THE PROXIMAL CONDUCTOR (NON-OBSTRUCTING), AND THE OUTER INSULATION WAS BREACHED/CUT. IT WAS APPARENT THAT DAMAGE OCCURED DURING EXPLANT. THE FULL LEAD WAS RETURNED FOR ANALYSIS. EVALUATION SUMMARY (B)(4) UPON ANALYSIS IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND, AND THERE WAS BLOOD/FLUID ON THE DISTAL CONDUCTOR (NON-OBSTRUCTING). THE FULL LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISLODGMENT OF THE LEFT VENTRICULAR LEAD TWO DAYS AFTER IMPLANT. THE LEAD WAS EXTRACTED AND REPLACED. DURING THE REVISION PROCEDURE THERE WAS DIFFICULTY POSITIONING/FIXING THE REPLACEMENT LEAD AND IT WOULD NOT STAY IN PLACE. THE REPLACEMENT LEAD WAS NOT IMPLANTED AND ANOTHER ONE WAS USED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB