BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 2418403 · Received January 17, 2012

    Report

    Report Number
    3004209178-2012-00297
    Event Type
    Injury
    Date Received
    January 17, 2012
    Report Date
    December 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL AND CATALOG NUMBER ACCIDENTALLY OMITTED.

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3389S-40 LOT# V011992 IMPLANTED: (B)(6) 2006 EXPLANTED: NA, EXTENSION MODEL 748251 SERIAL# (B)(4) IMPLANTED: (B)(6) 2006 EXPLANTED: (B)(6) 2011, NEUROSTIMULATOR MODEL 7426 SERIAL# (B)(4) IMPLANTED: (B)(6) 2011 EXPLANTED: NA, LEAD MODEL 3389S-40 LOT# V012196 IMPLANTED: (B)(6) 2006 EXPLANTED: NA, EXTENSION MODEL 748251 SERIAL# (B)(4) IMPLANTED: (B)(6) 2006 EXPLANTED: NA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE #0 CONTACT WAS DAMAGED ON THE LEAD. THE CONTACTS WERE LINED UP WITH THE EXTENSION, LEAVING THE #0 CONTACT OUT. THE PATIENT WAS DOING FINE AND WAS RECEIVING APPROPRIATE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP EXPERIENCED TELEMETRY ISSUES WHEN TRYING TO COMMUNICATE WITH THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS). AN X-RAY SHOWED THAT THE DEVICE WAS NOT FLIPPED. A DEAD BATTERY WAS POSSIBLE, AND IT WAS DETERMINED THAT THE DEVICE WOULD NEED TO BE REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT LOW OUT OF RANGE IMPEDANCE VALUES WERE SEEN ON ELECTRODE PAIR 0 & 1, APPROXIMATELY 35 OHMS. AN X-RAY SHOWED THAT THE PROXIMAL EXTENSION OF THE LEAD WAS STRIPPED. IT WAS UNCLEAR IF THE DAMAGE WAS FROM A PRIOR CHANGE OUT OR IF IT WAS RELATED TO THE PATIENT'S MULTIPLE FALLS. THE 0-1 CONTACT WAS SEVERELY KINKED AND THE 0 CONTACT WAS PULLED OUT OF THE EXTENSION. THE PHYSICIAN SEALED IT WITH SILICONE AT THE LEAD INSULATION. PREMATURE BATTERY DEPLETION WAS REPORTED. THE MANUFACTURER'S DEVICE REGISTRY SHOWED THAT THE INS AND EXTENSION WERE REPLACED IN A SURGICAL INTERVENTION. 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 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention