BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2880013 · Received December 19, 2012

    Report

    Report Number
    3004209178-2012-12046
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# V742349, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V742349, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD TO HAVE HER IMPLANTABLE NEUROSTIMULATOR (INS) RELOCATED FROM HER CHEST TO HER ABDOMEN "AROUND (B)(6) 2012" DUE TO WEIGHT LOSS. NO FURTHER INFORMATION WAS PROVIDED.

    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 Required Intervention