BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD (RIGHT-SIDED)

    MDR report key: 1012340 · Received February 12, 2008

    Report

    Report Number
    6000153-2008-01210
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    .

    Description of Event or Problem · 1

    THE REPRESENTATIVE REPORTED, THAT THERE HAD BEEN A LACK OF THERAPY BENEFIT, FACIAL PULLING HAD BEEN DETECTED ON THE LEFT SIDE OF THE PATIENT'S FACE WITH STIMULATION TURNED ON. PARAMETERS FOR THE RIGHT-SIDED INS WERE 1V, 90PW, 145 RATE, 1+, AND 2- WITH THERAPY IMPEDANCE GREATER THAN 2000 OHMS AT 9UA. IMPEDANCE READINGS OF 1733 AT 11UA WERE OBTAINED ON ALL UNIPOLAR PAIRS; IMPEDANCE READINGS ON ALL BIPOLAR PAIRS WERE GREATER THAN 2000 OHMS AT 9UA. IT WAS UNCLEAR IF THERE WERE ISSUES WITH THE LEFT-SIDED INS. THE BATTERY (IMPLANT SIDE WAS NOT SPECIFIED) WAS AT 3.74V. THESE PARAMETERS RIGHT-SIDE SYSTEM WERE COMPATIBLE WITH AN OPEN CIRCUIT, PALPATION OF THE LEAD/EXTENSION AND THE EXTENSION/INS CONNECTION AND X-RAYS WERE RECOMMENDED. THE PATIENT WAS RE-PROGRAMMED BY THE SURGEON IN 2008. PHYSICIAN NOTES WERE PROVIDED THAT SHOWED THE PATIENT APPEARED TO HAVE "SOME FACIAL PULLING". THE HCP BELIEVED THIS WAS "RELATED TO DYSTONIA AND NOT THE STIMULATION" AS HER STIMULATORS WERE OFF AT THE TIME." THE HCP NOTED, "HIGH IMPEDANCES AT THE BIPOLAR SETTINGS," THEREFORE; MONOPOLAR SETTINGS WERE USED DURING REPROGRAMMING. WITH STIMULATION TURNED ON, THE RIGHT-SIDED IPG WAS PROGRAMMED TO 3+, 2-, 90USEC PW, AT 145 HZ, WITH GOOD RESULTS NOTED. THE LEFT-SIDED IPG WAS REPROGRAMMED TO 1-, C+, 1.5V, 60USEC PW, AT 135 HZ; THE PATIENT HAD "SEEMED TO BE DOING QUITE WELL WITH THE ABOVE SETTINGS." THE PATIENT RETURNED FOR FOLLOW-UP (DATE WAS NOT PROVIDED), AND THE RIGHT-SIDED INS WAS TURNED OFF, PENDING FURTHER EVALUATION. THE LEFT-SIDED INS REMAINED TURNED ON. THE REPRESENTATIVE PROVIDED THAT THE INVESTIGATION WAS ON-GOING; THE CASE HAD NOT BEEN RESOLVED. ON MARCH 2008, THE PATIENT REPORTED THAT WITH STIMULATION TURNED ON, SHE HAD EXPERIENCED A RETURN OF DYSKINESIA SYMPTOMS THAT WERE SEVERE SHE HAD GONE TO THE HOSPITAL FOR TREATMENT. THE PHYSICIAN REPROGRAMMED THE INS THREE TIMES (DATES WERE NOT PROVIDED), BEFORE SOME RELIEF OF SYMPTOMS WAS OBTAINED. THE PATIENT INDICATED THE X-RAY EXAM HAD BEEN DONE (DATE WAS NOT REPORTED), WHICH DETERMINED THAT THE RIGHT-SIDED LEAD WIRES MAY BE LOOSE AND REQUESTED INFORMATION ON HOW THE ISSUE WOULD BE CORRECTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFER TO MFR REPORT #60000153200801208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD (RIGHT-SIDED) MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3389S V038036

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention EXPLANTED| R-SIDED IMPLANTABLE NEURO STIMULATOR MODEL 7426| RIGHT-EXTENSION MODEL 7482A LOT# NHU167033V| LOT# NFW143798H IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| LEFT-EXTENSION MODEL 7482A LOT# NHU158959V| LOT# NFW145597H IMPLANTED| PROGRAMMER MODEL UNK LOT# UNK IMPLANTED| LEFT-SIDED IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED