BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2325754 · Received November 5, 2011

    Report

    Report Number
    3007566237-2011-08986
    Event Type
    Injury
    Date Received
    November 5, 2011
    Date of Event
    June 27, 2011
    Report Date
    November 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LITERATURE: PERRUCHOUD C., BOVY M., DURRER A., ROSATO M., RUTSCHMANN B., MUSTAKI J.-P., BUCHSER E. 2011. SEVERE HYPERTENSION FOLLOWING ACCIDENTAL CLONIDINE OVERDOSE DURING THE REFILLING OF AN IMPLANTED INTRATHECAL DRUG DELIVERY SYSTEM. NEUROMODULATION 2011; E-PUB AHEAD OF PRINT. DOI: 10.1111/J.1525-1403.2011.00392.X SUMMARY: THE AUTHORS REPORT ON COMPLICATIONS ASSOCIATED WITH INTRATHECAL PUMPS THAT MAY BE LINKED TO THE SURGICAL PROCEDURE, THE IM PLANTED DEVICE, OR THE MEDICATION ITSELF. REPORTABLE EVENT: THE AUTHORS REPORT ON A (B)(6) FEMALE IMPLANTED WITH AN INTRATHECAL CLONIDINE PUMP IMPLANTED BECAUSE OF SEVERE LOW-BACK PAIN ATTRIBUTED TO A COMBINATION OF NEUROPATHIC AND MECHANICAL ORIGINS WITH AN ANCIENT COMPRESSION FRACTURE OF THE L1 VERTEBRAL BODY DUE TO OSTEOPOROSIS. OTHER RELEVANT MEDICAL DIAGNOSIS INCLUDED SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STABLE LEFT CARDIAC INSUFFICIENCY, AND WELL-CONTROLLED ARTERIAL HYPERTENSION. IT WAS NOTED, SIX MONTHS FOLLOWING IMPLANTATION, DURING A REFILL PROCEDURE THAT THE NEEDLE WAS BENT AND AN ACCIDENTAL POCKET INJECTION WAS SUSPECTED. THE PUMP CONTAINED CLONIDINE (1200 MG/ML) AND WAS PROGRAMMED AT A RATE OF 250MG/DAY. THE ESTIMATED DOSE THAT LEAKED IN THE SURROUNDING TISSUE WAS 22MG (18 ML). FIFTEEN MINUTES AFTER THE REFILLING PROCEDURE, THE PATIENT BECAME FIRST HYPOTENSIVE, PROFUSELY SWEATING, AND CONFUSED. SHE WAS ADMITTED IN THE INTENSIVE CARE UNIT WHERE SHE THEN PRESENTED WITH SEVERE HYPERTENSION (220/156 MMHG) AND A DYSARTHRIA. SHE RAPIDLY BECAME DYSPNOEIC (RESPIRATORY RATE 25/MIN, SPO2 75%). AUSCULTATION REVEALED DIFFUSE WHEEZING, THE CHEST X-RAY SHOWED FLUID OVERLOAD, AND AN ACUTE PULMONARY EDEMA DUE TO LEFT CARDIAC FAILURE SECONDARY TO THE HYPERTENSIVE CRISIS WAS DIAGNOSED. THE HYPERTENSION WAS SUCCESSFULLY TREATED WITH A CONTINUOUS NITRATES INFUSION (MAXIMUM RATE OF 0.2 MG/KG), ORAL AMLODIPINE, AND REPEATED INTRAVENOUS PHENTOLAMINE. THE ACUTE PULMONARY EDEMA RESPONDED TO INTRAVENOUS DIURETICS AND NON-INVASIVE VENTILATION. HEMODYNAMIC, RESPIRATORY, AND NEUROLOGICAL STATUS NORMALIZED WITHIN TWO DAYS AND NO LONG-TERM COMPLICATION WAS OBSERVED. THE AUTHORS INDICATED THAT THE "SHORTER DISTANCE, NEARLY 6 MM, BETWEEN THE OUTER BORDER OF THE SILICONE SEPTUM AND THE FLOOR IN THE RESERVOIR MAKES THE PUNCTURE MORE DIFFICULT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| L| R LEAD MODEL NEU_UNKNOWN_CATH LOT# UNK IMPLANTED: U