BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2468186 · Received February 24, 2012

    Report

    Report Number
    3007566237-2012-00388
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    December 14, 2010
    Report Date
    February 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL UNKNOWN, LOT# UNKNOWN, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN. THE ACTUAL EVENT DATE WAS NOT PROVIDED. THIS DATE IS BASED ON THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    LOOMBA, V., GUPTA, M., KIM, D. PERSISTENT HICCUPS WITH CONTINUOUS INTRATHECAL MORPHINE INFUSION. CLIN J PAIN 2012; 28: 172-174 SUMMARY: WE REPORT A CASE OF A (B)6) OLD MAN WHO DEVELOPED PERSISTENT HICCUPS WITH IT MORPHINE INFUSION PUMP THERAPY. THE HICCUPS PERSISTED DESPITE VARIOUS NONPHARMACOLOGICAL AND PHARMACOLOGICAL MEASURES. THE UNTOWARD SYMPTOM RESOLVED AFTER SUBSTITUTION OF IT HYDROMORPHONE FOR IT MORPHINE. THE PATIENT STARTED EXPERIENCING PERSISTENT HICCUPS APPROXIMATELY 12 HOURS AFTER THE INITIATION OF IT MORPHINE. HE WAS HAVING 6 TO 8 HICCUPS EVERY MINUTE. HE DID NOT EXPERIENCE ANY OTHER SIDE EFFECTS, AND HE REPORTED SATISFACTORY ANALGESIA IN BOTH UPPER EXTREMITIES. ALL KNOWN CAUSES OF HICCUPS, INCLUDING PREVIOUS HISTORY, UREMIA, ELECTROLYTE IMBALANCE, DIABETES MELLITUS, STROKE, ALCOHOLISM, AND DRUGS WERE RULED OUT. THE HICCUPS DID NOT RESOLVE ON INCORPORATION OF VARIOUS NONPHARMACOLOGICAL INTERVENTIONS SUCH AS DRINKING WATER, BREATH HOLDING, AND A VALSALVA MANEUVER. HE WAS PRESCRIBED 10MG OF BACLOFEN 1/2 - 0.1 TO 1 TAB T.I.D. PRO RENATA BUT CONTINUED TO HAVE PERSISTENT HICCUPS. AFTER 7 DAYS OF PERSISTENT HICCUPS, THE IT MORPHINE WAS REPLACED WITH HYDROMORPHONE BY ASPIRATING THE MEDICATION FROM THE PUMP CHAMBER, ASPIRATING THE IT CATHETER, AND USING A BRIDGE BOLUS. THE PUMP WAS FILLED WITH HYDROMORPHONE (10 MG/ML) INITIATED AT AN IT INFUSION RATE OF 0.481 MG/24 H. THE HICCUPS RESOLVED AFTER 12 HOURS. HE REMAINS SYMPTOM FREE 2 YEARS LATER AND IS EXPERIENCING GOOD PAIN RELIEF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention