BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1871042 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07837
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2010 THAT DURING A STAGE TWO IMPLANT, THE OBTURATOR INSIDE THE TUNNELING TOOL BROKE OFF INSIDE THE PT. THE OBTURATOR USED WAS THE LONG, FLAT ONE AND THEY WERE NOT SURE HOW IT BENT OR BROKE. THE TUNNELING TOOL WAS REMOVED, AS WAS THE MAIN PART OF THE OBTURATOR BUT THE TIP ITSELF REMAINED INSIDE THE PT. WE USED A DIFFERENT OBTURATOR AND FINALLY WERE ABLE TO TUNNEL THROUGH SUCCESSFULLY. THE FIRST PROGRAMMING SESSION ON 09/29/2010, INDICATED A SMALL BLEED (STABLE) IN THE LEFT FRONTAL LOBE ABOUT 2.5 X 1.5 CM ALONG THE TRAJECTORY OF THE LEFT LEAD; SOME SEIZURES WHILE IN RECOVERY, TREATED WITH KEPPRA; AND CONFUSION, SOME COGNITIVE IMPAIRMENT (WORD FINDING DIFFICULTY), SLURRED SPEECH, AND GAIT DIFFICULTY. NONE OF THIS WOULD/SHOULD HAVE ANYTHING TO DO WITH THE BROKEN OBTURATOR TIP. THE COMPANY REP PALPATED ALONG THE TRACT OF THE LEFT EXTENSION, BUT WAS UNABLE TO FEEL OR LOCATE THE IMPLANTED WEDGE TIP. PT COMPLAINED OF A "PULLING" SENSATION IN THE LOWER PORTION OF THE RIGHT EXTENSION, BUT THE BROKEN TIP WAS ON THE LEFT. PT DID NOT COMPLAIN OF ANY SHARPNESS, PAIN, PULLING OR DISCOMFORT ON THE LEFT SIDE. THE DEEP BRAIN STIMULATION PROGRAMMING WAS GENERALLY INEFFECTIVE AT TREATING THE PT'S SYMPTOMS (TREMOR, RIGIDITY), HAVING NO EFFECT ON TREMOR OR RIGIDITY IN THE RIGHT HAND/ARM, WITH SOME MINOR IMPROVEMENT IN THE RIGIDITY AND TREMOR IN THE ARM AND HAND TREMOR (FROM A 3/4 TO 2.5/4 ON A 4 POINT SCALE). ELECTRODE IMPEDANCES WERE VERY HIGH ON BOTH SIDES, FAILING IN ALL BIPOLAR COMBINATIONS (>2K OHMS WITH <12 UA CURRENT), AND MOST MONOPOLAR COMBINATIONS. THE MONOPOLAR COMBINATIONS THAT WERE IN-RANGE WERE HIGH (1500-1900 OHMS, CURRENT 12-15 UA). THERAPY IMPEDANCE WAS >2K ON THE LEFT HEMISPHERE, AND APPROX 1650 ON THE RIGHT HEMISPHERE WITH 25UA CURRENT. PT WAS ADVISED TO SEE THE SURGEON POTENTIALLY FOR A SURGICAL IMPEDANCE CHECK AND POSSIBLE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178-2010-07835.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT # V499735| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A, LOT # NJR219946V| EXPLANTED:| EXTENSION: MODEL 7482A, LOT # NHU219947V| EXPLANTED:| LEAD: MODEL 3387S, LOT # V488644| LOT # NFW165573H| IMPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL OBTURATOR, LOT # UNK| PROGRAMMER: MODEL 7438, LOT # NHL029854P