BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3071754 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05263
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. CONCOMITANT PRODUCTS: 4592 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY THAT THE PATIENT HAD A DOUBLE MASTECTOMY. SINCE THEN THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAS BEEN UNDEFINED. DURING TESTING THE HIGH, UNDEFINED RESISTANCE WAS CONFIRMED ALONG WITH NO CAPTURE. IT WAS SUSPECTED THAT THE LEAD WAS CUT OR FRACTURED DURING THE MASTECTOMY. THE RV 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
    171125 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)