BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5402450 · Received February 1, 2016

    Report

    Report Number
    3007566237-2016-00501
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    January 11, 2016
    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

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    HUH, B., ROLDAN, C.J. MAGNETIC FIELDS AND INTRATHECAL PUMP MALFUNCTION. AMERICAN JOURNAL OF EMERGENCY MEDICINE. 2016. 34 (115.E5¿115.E6). DOI: 10.1016/J.AJEM.2015.04.084. SUMMARY/ REPORTED EVENTS: A (B)(6 YEAR-OLD MAN WITH HISTORY OF MULTIPLE MYELOMA ON REMISSION AND A RECENTLY IMPLANTED IDDS (INTRATHECAL DRUG DELIVERY SYSTEM) FOR CHRONIC BACK PAIN VISITED THE EMERGENCY DEPARTMENT WITH INCREASED PAIN AND SYMPTOMS OF OPIATE WITHDRAWAL. HE REPORTED APPROXIMATELY 12 HOURS OF NAUSEA, VOMITING, ABDOMINAL CRAMPS, DIARRHEA, RHINORRHEA, INCREASED BACK PAIN, AND FATIGUE. HE CLAIMED TO BE FAMILIAR WITH THESE SYMPTOMS BECAUSE HE HAD EXPERIENCED PRIOR OPIATES WITHDRAWAL. EVALUATION REVEALED AN IRRITABLE-APPEARING MAN. HE WAS AFEBRILE WITH BLOOD PRESSURE OF 159/92 MM HG AND HEART RATE OF 112 BEATS/MIN. HIS PHYSICAL EXAMINATION WAS UNREMARKABLE FOR ACUTE FINDINGS, EXCEPT FOR DRYNESS OF ORAL MUCOSA, PILOERECTION, AND CONSTANT YAWNING. AN IDDS WAS PALPABLE AT HIS LEFT PARAUMBILICAL AREA OF THE ABDOMINAL AND HAD NO SIGNS OF INFECTION OR LOCALIZED TENDERNESS. HIS PUMP WAS NOT ON THE RECALL LIST. BASIC LABORATORY VALUES WERE WITHIN NORMAL LIMITS, AND HIS SYMPTOMS IMPROVED WITH INTRAVENOUS FLUIDS, ANTIEMETICS, AND OPIATE ANALGESICS. A DEVICE INTERROGATION REVEALED A RECORD OF FREQUENT PUMP-MOTOR STALL. THERE WERE MULTIPLE MOTOR STALL EVENTS IN THE EVENT LOG. THE PATIENT DID NOT RECALL ANY EXPOSURE TO MAGNETIC FIELDS OR MAGNETIC RESONANCE IMAGING (MRI). A CATHETER DYE STUDY DID NOT REVEAL LEAKAGE OR KINKS. AFTER A MORE DETAILED HISTORY TAKING, IT WAS CONCLUDED THE PATIENT¿S REPETITIVE PLACEMENT OF LAPTOP COMPUTER ON HIS ABDOMEN AND MAY HAVE AFFECTED THE FUNCTION OF PROGRAMMABLE PUMP. THE MAGNETS IN THE LAPTOP SPEAKERS MAY HAVE CAUSED THE ROTOR OF THE PUMP MOTOR TO STALL AND FREQUENT STALL CAUSED SYMPTOMS OF WITHDRAWAL. APPARENTLY, THE MAGNETIC FIELD OF THE SPEAKERS HAD CAUSED THE PUMP-MOTOR STALLING. THE PATIENT WAS DISCHARGED HOME AFTER PUMP REPROGRAMMING AND WITH INSTRUCTIONS TO AVOID PLACING HIS LAPTOP COMPUTER ON THE ABDOMEN. FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN THE DRUG BEING DELIVERED VIA THE DEVICE, PATIENT IDENTIFICATION, DEVICE INFORMATION AND THE EVENT DATE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61726 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR