BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1926219 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14236
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND, THERE WAS BLOOD/FLUID ON ALL CONDUCTORS (NON-OBSTRUCTING), AND ALL INSULATORS WERE MELTED. APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISLODGEMENT AND A CUT IN THE INSULATION OF LEFT VENTRICULAR LEAD. WHILE ATTEMPTING TO REPOSITION, THE PHYSICIAN BOVIED THROUGH THE LEAD AND CUT THE LEAD INTO TWO PIECES. THE REMAINING PORTION OF THE LEAD WAS CAPPED; THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 6935 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD