BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2664822 · Received July 23, 2012

    Report

    Report Number
    3004209178-2012-05948
    Event Type
    Injury
    Date Received
    July 23, 2012
    Report Date
    June 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT; PRODUCT ID 37085-60, LOT#, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V884064, SERIAL#, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. PHYSICIAN WAS GOING TO REMOVE THE BATTERY, CAP OFF THE EXTENSION USING AN EXTENSION AND BOOT, AND REMOVE THE EXTENSION AFTER THE INFECTION HAD HEALED. APPROXIMATELY A WEEK LATER IT WAS REPORTED THAT THE BATTERY AND PART OF THE EXTENSION WAS REMOVED. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention