BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1923160 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13278
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    July 1, 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
    MA, 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 WERE FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT ON DISTAL CONDUCTOR (NOT OBSTRUCTED).

    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 WERE FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT ON DISTAL CONDUCTOR (NOT OBSTRUCTED). (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED HIGH IMPEDANCE WAS RECORDED. VENTRICULAR PACE LEAD IMPEDANCE RISES STEADILY FROM AN APPROXIMATE BASELINE OF 375 OHMS THE WEEK OF (B)(6) 2010 TO A HIGH OF 1840 OHMS THE WEEK OF (B)(6) 2010. NO PATIENT ALERTS ARE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXPERIENCED INCREASED IMPEDANCES, HIGH IMPEDANCES, AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD COULD NOT BE IMPLANTED DUE TO PATIENT ANATOMY. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS NOT USED, AND REPLACED WITH A NEW LEAD. 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 65 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB