BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2747135 · Received September 17, 2012

    Report

    Report Number
    3004209178-2012-08180
    Event Type
    Injury
    Date Received
    September 17, 2012
    Report Date
    August 27, 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

    PRODUCT ID: 7482A51, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7482A51, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7428, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 64002, LOT #: N274424, PRODUCT TYPE: ADAPTER; PRODUCT ID: 37642, SERIAL #: (B)(4), PRODUCT TYPE: PROGRAMMER, PRODUCT ID: 3387S-40, LOT #: V037049, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT #: V040632, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THAT PATIENT'S PHYSICIAN BROUGHT IN THE PATIENT FOR A SURGICAL PROCEDURE TO MOVE HER IMPLANTABLE NEUROSTIMULATOR (INS) FROM HER RIGHT CHEST TO HER RIGHT ABDOMEN DUE TO COMPLAINTS OF PAIN AND EXCESSIVE "BULK" FROM THE INS POCKET. IT WAS NOTED THAT THE INS POCKET CONTAINED BOTH AN INS (MODEL #: 37601) AND AN ADAPTOR (MODEL #: 64002) FROM A PREVIOUS TRANSITION FROM AN OLDER INS TO HER CURRENT ONE. UPON INCISION, PUS WAS OBSERVED TO HAVE COLLECTED IN THE RIGHT CHEST INS POCKET AND THE PHYSICIAN WAS FORCED TO EXPLANT THE INS, ADAPTOR, AND THE BILATERAL LEGACY EXTENSIONS (MODEL #: 7482A51). IT WAS DETERMINED THAT THE PATIENT WAS TO BE TREATED FOR INFECTION AND WOULD BE WITHOUT DBS THERAPY FOR A PERIOD OF TIME TO BE DETERMINED. IT WAS NOTED THAT THE PHYSICIAN COMPLAINED AS WELL ABOUT THE EXCESSIVE BULK THAT THE REQUIRED ADAPTOR PRODUCED WHILE IN THE INS POCKET. ADDITIONAL INFORMATION REPORTED THAT THE DATE OF THE ONSET OF INFECTION WAS UNKNOWN. THE INFECTION WAS CULTURED, BUT THE RESULTS WERE UNAVAILABLE AT THE TIME OF THE REPORTED INFORMATION. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. IT WAS UNKNOWN IF THE INFECTION HAD RESOLVED, BUT THE PATIENT WAS CURRENTLY RECOVERING AT THE TIME OF THE REPORTED INFORMATION. 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention