BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2870822 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11771
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37092 LOT# 318250001, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40 LOT# V952317, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V952317, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS EROSION AT THE POCKET SITE OF THE LEFT SIDE IMPLANT. THERE WAS NO EROSION THROUGH THE SKIN. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT. SURGICAL INTERVENTION WAS REQUIRED. DEVICE WAS PLACED DEEPER TO PREVENT EROSION AND REDUCE TIGHTNESS. FOLLOW UP REPORTED THERE WAS NOTHING MORE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention