BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIX

    MDR report key: 2790442 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14137
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5072

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR| 5072 IMPLANTABLE PACING LEAD