BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3062156 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05118
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS, CO. VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. CONTINUATION OF DEVICE: VEDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2007; 4592 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD FRACTURED. THE 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
    163138 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS, CO. VILLALBA 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R