BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2121583 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07804
    Event Type
    Injury
    Date Received
    June 13, 2011
    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
    KS, 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) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, THERE WERE NO IMPEDANCE MEASUREMENTS FOR THE LAST FEW WEEKS. THE DEVICE WAS AT PREMATURE ELECTIVE REPLACEMENT INDICATOR AND WAS EXPLANTED AND REPLACED. THE RIGHT AND LEFT VENTRICULAR LEADS WERE CAPPED AT DEVICE EXPLANT DUE TO HIGH THRESHOLDS. 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. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) HEART RING| 4968 IMPLANTABLE PACING LEAD