BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFY

    MDR report key: 1000051 · Received February 15, 2008

    Report

    Report Number
    2182207-2008-00687
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    November 1, 2007
    Report Date
    January 17, 2008
    Manufacturer
    MEDTRONIC INC. NEUROLOGICAL DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K971756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT'S HUSBAND HAD PREVIOUSLY REPORTED, THAT WHEN THE NEUROSTIMULATOR WAS TURNED ON, IT CAUSED HIS WIFE (THE PATIENT) TO HAVE ACUTE PAIN AND DIFFICULTY WALKING. THE PAIN WAS LOCATED AT THE PARESTHESIA AREA. HE INCLUDED THAT IN 2007, "IT WAS SO PAINFUL THAT SHE FELL DOWN AND HIT HER HEAD". SEE MANUFACTURER'S REPORT # 6000032200800049. THE HCP REPORTED, THAT INITIALLY THE PT'S NEUROSTIMULATOR WAS SOMEWHAT HELPFUL, BUT ABOUT 2 OR 3 YEARS AGO, THE STIMULATOR STOPPED FUNCTIONING PROPERLY WHEN THE PT TURNED IT ON; IT GAVE HER A PAINFUL SENSATION IN HER LOWER EXTREMITIES. SHE HAD NOT SEEN HER NEUROSURGEON MANAGING HER NEUROSTIMULATOR ABOUT THIS. THEN ABOUT 2 TO 6 MONTHS AGO, SHE BEGAN HAVING INCREASING LOW BACK AND LOWER EXTREMITY PAIN WITH BOTH NUMBNESS AND WEAKNESS. HER SYMPTOMS RADIATED FROM THE LOWER BACK REGION TO THE POSTERIOR ASPECT OF HER LOWER EXTREMITIES. SHE COULD STAND AND AMBULATE WITHOUT DIFFICULTY. THE PT DESCRIBED THE SYMPTOMS AS INTERMITTENT AND STABBING. IT FLARED UP SPONTANEOUSLY AND IMPROVED WHEN SHE WAS LYING DOWN. SHE ALSO REPORTED A 2 WEEK HISTORY OF INTERMITTENT BLADDER/BOWEL INCONTINENCE. SHE WAS ADMITTED TO THE HOSPITAL IN 2007 DUE TO THE INCREASING PAIN AND INCONTINENCE. ON THE EXAM, THE HCP REPORTED, SHE HAD TENDERNESS ON PALPATION OF THE LUMBOSACRAL REGION; HER STRAIGHT LEG EXTENSION WAS NEGATIVE FOR NEURAL TENSION SIGNS; SHE HAD INTACT SENSATION TO TEMPERATURE IN THE LOWER EXTREMITIES; HER REFLEXES APPEARED SYMMETRICAL AND BRISK. THE PT HAD BEEN ON A DURAGESIC PATCH WITH HYDROCODONE FOR BREAKTHROUGH PAIN. SHE WAS ALSO TAKING VALIUM, ZOLOFT, RESTORIL, TYLENOL, DILAUDID, LORAZEPAM, ZOFRAN, PHENERGAN, AND AMBIEN. A CT SCAN WAS DONE OF THE CERVICAL, THORACIC, AND LUMBAR SPINE (DATE NOT REPORTED). THE CT SCAN OF THE CERVICAL SPINE REVEALED BONY CERVICAL CANAL WITHIN NORMAL LIMITS. THE CT SCAN OF THE THORACIC SPINE REVEALED ELECTRODE WIRES IN THE BONY CANAL OF THE MID-THORACIC SPINE WITH WIRES EXTENDING THROUGH THE INTERSPINOUS LAMINA INTO THE SOFT TISSUES POSTERIOR TO THE SPINE. NO ACUTE ABNORMALITIES WERE NOTED. THE CT SCAN OF THE LUMBOSACRAL SPINE REVEALED NO ACUTE ABNORMALITIES AND NO DEFINITE MASS EFFECTS ON THE DURAL SAC; HOWEVER, STUDY WAS TERMED "INSENSITIVE" FOR DETECTING SUCH MASS EFFECTS. A LAMINECTOMY DEFECT ON THE RIGHT AT L3 WAS NOTED. MILD DEGENERATIVE ARTHROPATHY OF THE FACET JOINTS OF THE LOWER LUMBAR SPINE WAS NOTED. THE HCP RECOMMENDED, THAT THE PT FOLLOW-UP WITH THE NEUROSURGEON MANAGING HER NEUROSTIMULATOR FOR POSSIBLE REPROGRAMMING OF THE DEVICE. THE HCP ALSO NOTED, THAT HER CURRENT ANALGESIC MEDICATIONS WERE REASONABLE AND BEING MANAGED BY HER PRIMARY CARE PHYSICIAN; HOWEVER, HE RECOMMENDED THAT IF HER SYMPTOMS WERE TO IMPROVE, WEANING FROM THE MEDICATIONS SHOULD BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIFY GZB MEDTRONIC INC. NEUROLOGICAL DIVISION 3998 LA7870

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 7435| LOT# NHK019373V| IMPLANTED| EXTENSION MODEL 7495LZ51| NEUROSTIMULATOR MODEL 7427| LOT # NFT013699P| EXPLANTED| IMPLANTED| IMPLANTED| LOT# NHK020840V| EXTENSION MODEL 7495LZ