BEUDAMED
    FDA Adverse Event Summary report: N

    ATTAIN OTW

    MDR report key: 1861432 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-09965
    Date Received
    October 8, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM. OUTER INSULATION WAS MELTED, THE LEAD WAS STRETCHED. SOME TISSUE INGROWTH WAS NOTED AT THE DISTAL TIP AREA, BUT IT COULD NOT BE DETERMINED IF THIS COULD HAVE AFFECTED POSITIONING. IT CANNOT BE DETERMINED AT THIS TIME, BUT LIKELY THE BLOOD IN THE OVERLAY TUBING RESTRICTED DEPLOYMENT.

    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 FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM. OUTER INSULATION WAS MELTED, THE LEAD WAS STRETCHED. SOME TISSUE INGROWTH WAS NOTED AT THE DISTAL TIP AREA, BUT IT COULD NOT BE DETERMINED IF THIS COULD HAVE AFFECTED POSITIONING. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR, IN THE OUTER TUBING, AND IN/ON THE HELIX MECHANISM. LEAD WAS STRETCHED. IT CANNOT BE DETERMINED AT THIS TIME, BUT LIKELY THE BLOOD IN THE OVERLAY TUBING RESTRICTED DEPLOYMENT. (B)(4). 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. CORRECTED DATA - ADVERSE EVENT FLAG, PATIENT DATA OF DEATH, ALERT DATE, EVENT DATE, REPORT SOURCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSITIONING/FIXATION DIFFICULTY. THE LEFT VENTRICULAR LEAD WAS REPLACED. DURING IMPLANT ATTEMPT OF A NEW LEFT VENTRICULAR LEAD, THE LEAD WAS UNABLE TO GET INTO THE VEIN. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSITIONING/FIXATION DIFFICULTY. THE LEFT VENTRICULAR LEAD WAS REPLACED. DURING IMPLANT ATTEMPT OF A NEW LEFT VENTRICULAR LEAD, THE LEAD WAS UNABLE TO GET INTO THE VEIN. THE LEAD WAS NOT USED. THE DEVICE WAS ALSO REPLACED DUE TO PREMATURE BATTERY DEPLETION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S TESTING. 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 ASKU DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD