BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 2122489 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07858
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K851890
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PAIN FROM MID-STERNUM TO PACEMAKER POCKET WITH THE MAGNET APPLICATION TO THE DEVICE. IT WAS ALSO REPORTED THERE WAS EXTRANEOUS STIMULATION AND A REQUEST FOR ASSESSMENT OF THE BATTERY STATUS. ELECTIVE REPLACEMENT WAS INDICATED AND THE DEVICE WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLD AND LOW IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET TIP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5064 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R