BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 2811761 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16140
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SYNCOPE AND A PACEMAKER CHECK FOUND THAT THE LEAD WAS NOT PACING. EVEN AT MAXIMUM OUTPUTS, THE LEAD WOULD ONLY PACE INTERMITTENTLY. TEMPORARY PACING WAS PERFORMED UNTIL THE LEAD WAS CAPPED AND REPLACED. NO FURTHER 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. 4511

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R ADSR06 IMPLANTABLE PULSE GENERATOR