BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2696976 · Received August 14, 2012

    Report

    Report Number
    3004209178-2012-06881
    Event Type
    Injury
    Date Received
    August 14, 2012
    Report Date
    July 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708660, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION: PRODUCT ID 37085-60, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION: PRODUCT ID 3387S-40, LOT# V971421, SERIAL# IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYPE LEAD. PRODUCT ID 3387S-40, LOT# V799769, SERIAL# IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# V971421, IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION IN THE DEVICE POCKET AND EXTENSION LOCATION. THE INFECTIOUS ORGANISM WAS UNKNOWN AND NO TUNNEL TOOL WAS USED WHEN REMOVING THE EXTENSION. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT TWO LEADS WERE REMOVED DUE TO INFECTION. THE LOCATION OF THE SYMPTOM/ISSUE WAS REPORTED AS DEVICE POCKET, LEAD EXTENSION CONNECTION LOCATION, EXTENSION LOCATION, AND LEAD LOCATION. IT WAS REPORTED THAT THE LEADS WOULD NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS REPORTED AS ALIVE WITH NO INJURY AND NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Required Intervention