BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4667583 · Received April 8, 2015

    Report

    Report Number
    3004209178-2015-06137
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MEDTRONIC 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V273701, IMPLANTED: 2009-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V233444, SERIAL# IMPLANTED: 2009-(B)(6), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION ABOUT A MONTH AFTER IMPLANT SURGERY. THE BACK OF THE PATIENT¿S HEAD WAS VERY SORE AND A LUMP WAS FELT ABOUT A MONTH AFTER SURGERY. THE LUMP WAS POSTERIOR TO THE CONNECTION. THE INFECTION HAD CLEARED UP WITH MEDICATION, BUT THE PATIENT DID NOT THINK THE INFECTION HAD CLEARED UP UNTIL TWO WEEKS PRIOR TO THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178-2015-06135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231435 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention