BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953397 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01053
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K932172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 CONTINUED: (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2001. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL SPELL AND WAS HOSPITALIZED. THE DOCTOR SUSPECTED MYOPOTENTIAL OVERSENSING OR ELECTROMAGNETIC INTERFERENCE (EMI) INHIBITION OF THE LEAD. AFTER AN EXTENSIVE WORKUP, THE DOCTOR COULD NOT REPRODUCE ANYTHING. THE LEAD REMAINS IN USE. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57676 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4557M-53

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening (B)(4) IMPLANTABLE PULSE GENERATOR