BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1892362 · Received November 3, 2010

    Report

    Report Number
    3007566237-2010-08845
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FLACCID IN LOWER LIMBS; HYPERREFLEXIA; ATROPHY; PARAPARESIS; LOSS OF SPHINCTER TONE AND BOWEL AND BLADDER DYSFUNCTION. (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: DE ANDRES J, PALIMISANI S, VILLANUEVA PV, L'ASENSIO J, LOPEZ-ALARCON MD. CAN AN INTRATHECAL, CATHETER-ASSOCIATED INFLAMMATORY MASS REOCCUR? THE CLINICAL JOURNAL OF PAIN, 2010; 26(7):631. SUMMARY: THE AUTHORS REPORT THE CASE OF A PT WHO DEVELOPED AN INTRATHECAL GRANULOMA ON 3 OCCASIONS AND THE USE OF AN ALTERNATIVE THERAPEUTIC STRATEGY WHICH HELPED TO AVOID SURGERY AND THE DISCONTINUATION OF THE INTRATHECAL INFUSION. EVENT: ONE WAS TREATED WITH HIGH-DOSE INTRATHECAL MORPHINE BLENDED IN DIFFERENT COMBINATIONS WITH BUPIVACAINE AND CLONIDINE. IN EARLY 2003, MRI REVEALED AN INTRADURAL MASS AT T10 CONSISTENT WITH THE LOCATION OF THE DISTAL TIP OF THE CATHETER WITH PROGRESSIVE MOTOR WEAKNESS AND ATTACKS OF STABBING NEUROPATHIC PAIN AND FLACCIDITY IN HER LOWER LIMBS WITH THE ABSENCE OF ANKLE JERK REFLEX, DIMINISHED PATELLAR REFLEX, AND ALTERED THERMAL SENSITIVITY IN THE RIGHT LOWER LIMB. THE MASS WAS SURGICALLY REMOVED BUT THE ANTERIOR POLE HAD PENETRATED THE SPINAL CORD, INJURING THE POSTERIOR FUNICULI, WHEREAS ITS POSTERIOR POLE HAD ENCOMPASSED THE POSTERIOR ROOTS. THE CATHETER WAS RESECTED AND PLACED ONE VERTEBRAL SEGMENT MORE CAUDALLY. FIVE MONTHS AFTER THIS SURGERY, THE PT DEVELOPED SYMPTOMS OF NEUROLOGIC DETERIORATION SUGGESTING RADICULAR OR SPINAL CORD COMPRESSION. PT HAD INCREASED LOCAL BACK PAIN, SOMETIMES WITH RADICULAR PAIN AND HYPERREFLEXIA AND LOSS OF SENSATION. ASYMMETRIC MUSCLE STRETCH REFLEXES AND FOCAL MYOTOMAL WEAKNESS WITH ATROPHY WERE NOTED. A FURTHER MRI SHOWED A NEW GRANULOMA AT THE TIP OF THE CATHETER AT T11 TO T12. THE PT WAS SCHEDULED AGAIN FOR AN EXTENDED LAMINECTOMY WITH RESECTION OF THE RECURRENT GRANULOMA TISSUE. FOR 3 YEARS, THE PT HAD SATISFACTORY PAIN CONTROL NEVERTHELESS; PROGRESSIVE NEUROLOGIC DEFICIT SYMPTOMS OF ADVANCED SPINAL CORD COMPRESSION WERE DEVELOPED ALONG THE YEARS WITH SEGMENTAL DEFICITS, PARAPARESIS, HYPERREFLEXIA, EXTENSOR PLANTAR RESPONSES, AND LOSS OF SPHINCTER TONE WITH BOWEL AND BLADDER DYSFUNCTION. AN MRI SCAN AGAIN REVEALED AN INTRATHECAL GRANULOMA AT T11 TO T12 LEVEL SURROUNDING CATHETER TIP. THE PT REFUSED TO UNDERGO SURGERY AND ACCEPTED HER PROGRESSIVE NEUROLOGIC DEFICIT. A PLAN WAS DEVISED TO REPLACE THE CATHETER PERCUTANEOUSLY IN AN ATTEMPT FOR THE GRANULOMA TO REGRESS; THERE WERE NO INTRA OR POSTOPERATIVE COMPLICATIONS. THE PT WAS SWITCHED TO ZICONOTIDE OBTAINING A SATISFACTORY PAIN RELIEF OF MORE THAN 50% AFTER 10 DAYS. ONE YEAR LATER, THERE WERE NO SYMPTOMS AND NO EVIDENCE OF NEW GRANULOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK