BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8261132 · Received January 18, 2019

    Report

    Report Number
    3004209178-2019-01305
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    January 16, 2019
    Report Date
    January 18, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBERS OF THE ENTIRE SYSTEM WERE KNOWN; HOWEVER, IT WAS NOT KNOWN WHICH SERIAL NUMBERS SPECIFICALLY APPLIED TO THE LEFT LEAD AND LEFT EXTENSION. BELOW IS THE INFORMATION FOR THE ENTIRE SYSTEM: EXTENSION SERIAL NUMBER: (B)(4), IMPLANT DATE: (B)(6) 2008, MFG DATE: 2008-06-06, UBD: 2012-06-06. EXTENSION SERIAL NUMBER: (B)(4), IMPLANT DATE: (B)(6) 2007, MFG DATE: 2007-07-13, UBD: 2011-07-13. EXTENSION SERIAL NUMBER: (B)(4), IMPLANT DATE: (B)(6) 2007, MFG DATE: 2007-07-25, UBD: 2011-07-25. LEAD LOT NUMBER: B0726294K, IMPLANT DATE: (B)(6) 2007, MFG DATE: 2007-06-18, UBD: 2011-06-18. LEAD LOT NUMBER: B0726293K, IMPLANT DATE: (B)(6) 2007, MFG DATE: 2007-06-18, UBD: 2011-06-18. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION OF THEIR LEFT SIDE DBS BRAIN LEAD AND HAD THEIR ENTIRE LEFT SIDE DBS SYSTEM EXPLANTED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53768 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention