BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5230974 · Received November 17, 2015

    Report

    Report Number
    3007566237-2015-03053
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID 8590-1, LOT# N220809, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4). MDR SUBMITTED AFTER DUE DATE, BECAUSE OF AN OUTAGE WITH FDA. REFERENCE FDA TICKET (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT RECEIVING BUPIVACAINE 5 MG/ML AT 1.512 MG/DAY, AND DILAUDID 8 MG/ML AT 2.42 MG/DAY VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE (IFU) WAS LISTED AS NON-MALIGNANT PAIN, CHRONIC PAIN, AND POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE PATIENT'S ALARM WAS HEARD ON (B)(6) 2015. THE ALARM WAS HEARD, BUT TELEMETRY HAD NO YET BEEN PERFORMED. THE REASON FOR THE ALARM WAS UNKNOWN. THE PATIENT NEEDED TO FIND A DOCTOR TO REFILL THE PUMP, BUT HAD BEEN UNSUCCESSFUL. THE PATIENT WAS TRAVELING FOR WORK AND ENDED UP GOING TO THE EMERGENCY ROOM (ER) ON (B)(6) 2015 BECAUSE THE PUMP WAS EMPTY. A HEALTHCARE PROFESSIONAL WAS ATTEMPTING TO ASSIST THE PATIENT IN LOCATING A PHYSICIAN THAT WILL FILL THE PUMP WHILE THE PATIENT IS AWAY. THE HCP HAD NOT SEEN THE PATIENT IN A YEAR, BUT REPORTED THE PATIENT HAS HAD THEIR PUMP FILLED IN OTHER PLACES SINCE THEY LAST SAW THE PATIENT. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761399 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR