BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIX ST

    MDR report key: 3862462 · Received June 10, 2014

    Report

    Report Number
    2647346-2014-00052
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWO
    PMA / PMN Number
    P850051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) DURING A PREVIOUS CHECK-UP, BUT THE DEVICE WAS NEVER CHANGED OUT. THE PATIENT NOW FELT SYMPTOMS OF PACEMAKER SYNDROME. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338200 MINIX ST PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE LWO MDT PUERTO RICO OPERATIONS CO, MED REL 8331M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4003M58 LEAD