BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2897401 · Received January 4, 2013

    Report

    Report Number
    3007566237-2013-00040
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    July 26, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT TO A PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    KOSTURAKIS, A., GEBHARDT, R. SYNCHROMED II INTRATHECAL PUMP MEMORY ERRORS DUE TO REPEATED MAGNETIC RESONANCE IMAGING. PAIN PHYSICIAN. 2012;15(6):475-477. SUMMARY: CANCER PATIENTS WITH SEVERE REFRACTORY PAIN ARE OFTEN MANAGED WITH IMPLANTABLE DRUG DELIVERY SYSTEMS (IDDS). THE ONLY DRUGS WITH US FOOD AND DRUG ADMINISTRATION APPROVAL FOR INTRATHECAL USE ARE MORPHINE, ZICONOTIDE, AND BACLOFEN. OTHER DRUGS USED AND MIXED INCLUDE, HYDROMORPHONE, BUPIVACAINE, SUFENTANIL, AND FENTANYL. THESE PATIENTS OFTEN UNDERGO MAGNETIC RESONANCE IMAGING (MRI) FOR DISEASE-RELATED MONITORING AND DIAGNOSES. ALTHOUGH UNCOMMON, IDDS CAN FAIL TO RESUME NORMAL FUNCTIONING AFTER MRI, POTENTIALLY CAUSING COMPLICATIONS. THE MAGNETIC FIELD OF AN MRI WILL TEMPORARILY STOP THE ROTOR OF THE PUMP MOTOR AND SUSPEND DRUG DELIVERY FOR THE DURATION OF THE MRI EXPOSURE. THE PUMP SHOULD RESUME NORMAL OPERATION WHEN REMOVED FROM THE MRI MAGNETIC FIELD, BUT THERE IS A POTENTIAL FOR A DELAY IN THE RETURN OF PROPER DRUG INFUSION AND A DELAY IN THE LOGGING OF MOTOR STALL EVENTS AFTER AN MRI IN THE SYNCHROMED II PUMPS. A (B)(6) MAN WHO UNDERWENT MULTIPLE MRIS WITH AN IMPLANTED IDDS EXPERIENCED 2 SEPARATE MEMORY FAILURES LEADING TO MULTIPLE COMPLICATIONS. AFTER THE FIRST PUMP MALFUNCTION, THE PATIENT DEVELOPED WITHDRAWAL SYMPTOMS AND WAS TREATED IN THE EMERGENCY DEPARTMENT. THE FIRST TIME, A MEMORY RESET RESOLVED THE PROBLEM. THE SECOND TIME, 29 MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL TO MANAGE WITHDRAWAL SYMPTOMS AND THE PUMP HAD TO BE EXCHANGED WITH A NEW DEVICE. POST-MRI PUMP INTERROGATION SHOULD BE PERFORMED ON ALL PATIENTS WITH IDDS TO ENSURE PROPER FUNCTIONING OF THE PUMP. SPECIAL ATTENTION SHOULD BE PAID TO PATIENTS RECEIVING BACLOFEN, AS ACUTE WITHDRAWAL CAN BE VERY SERIOUS, EVEN DEADLY. REPORTED EVENT: OVER THE NEXT 2.5 YEARS THE PATIENT UNDERWENT 7 MORE MRIS. IT WAS VERIFIED BY INTERROGATION THAT THE IDDS RESUMED NORMAL FUNCTION. AT THIS POINT THE ANALGESIC SOLUTION HAD BEEN CHANGED TO FENTANYL 1,000 MCG/ML, CLONIDINE 300 MCG/ML, BUPIVACAINE 10 MG/ML, AND BACLOFEN 150 MCG/ML. THE PUMP WAS DELIVERING A DOSE OF 275 MCG/D FENTANYL, 2.75 MG/D CLONIDINE, 2 MG/D BUPIVACAINE, AND 41.25 MCG/D BACLOFEN. THE PATIENT HAD SOME TROUBLE WITH EJACULATION AFTER THE ADDITION OF BACLOFEN TO THE MIXTURE AND HAD AN MRI OF THE SPINE TO RULE OUT ANY INTRATHECAL GRANULOMA (11). THE DAY AFTER HE UNDERWENT AN MRI, HE WAS SEEN FOR INCREASED PAIN AND WITHDRAWAL SYMPTOMS. INTERROGATION OF THE PUMP WAS ATTEMPTED USING 3 DIFFERENT HAND HELD DEVICES, AND ALL INDICATED A MALFUNCTION ALERT. THE PATIENT WAS GIVEN 400 MCG FENTANYL CITRATE LOZENGE, FENTANYL 25 MCG TRANSDERMAL PATCH, 20 MG ORAL BACLOFEN, AND CLONIDINE 0.1 MG PATCH. ALL MEDICATION WAS REMOVED FROM THE PUMP, REPLACED WITH SALINE, AND THE PATIENT WAS ADMITTED FOR 23 HOUR OBSERVATION THROUGH THE EMERGENCY DEPARTMENT. THE MALFUNCTIONING PUMP WAS EXPLANTED AND REPLACED WITH A NEW PUMP, WHICH WAS REFILLED WITH THE AFOREMENTIONED MEDICATIONS. THE EXPLANTED PUMP WAS SENT TO MEDTRONIC FOR ANALYSIS AND THEY REPORTED NO VISUAL ANOMALY AND THAT THE PUMP WAS FUNCTIONING PER SPECIFICATION. FLOW TESTING CONFIRMED THE PUMP WAS DISPENSING ACCURATELY. THE PUMP MEMORY ERROR WAS LIKELY A PROGRAMME R-INDICATED ISSUE AND CLEARED AFTER INITIALIZING. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4644 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER MODEL: UNK SERIAL/LOT#: UNK