BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2890662 · Received December 31, 2012

    Report

    Report Number
    3007566237-2012-03156
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 2, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED THE PUMP LOGS SHOWED THAT ON (B)(6) 2012 THE PUMP WAS IN SAFE STATE; LOW BATTERY RESET OCCURRED. THE PUMP WAS PROGRAMMED TO DELIVER FLEX MODE AND THE PATIENT HAD BEEN RECEIVING BOLUSES EVERY 6 HOURS. THE HCP ATTEMPTED TO UPDATE THE PUMP ON (B)(6) 2012 AT 14:55. AT 14:56, THE PUMP REVERTED TO SAFE STATE WITH LOW BATTERY RESET, AND RESET OCCURRED. THE PATIENT EXHIBITED SYMPTOMS OF WITHDRAWAL AND WAS "JERKING." IT WAS NOTED THE PATIENT EXPERIENCED SEPSIS, AND HAD A SEPTIC JOINT. THE PATIENT WAS SCHEDULED FOR A REPLACEMENT IN (B)(6) (YEAR NOT REPORTED), BUT THAT TIMEFRAME WILL BE MOVED UP. THE HCP PLANNED TO START AN IV TO TREAT THE PATIENT. THE REPORTER WAS IN CONTACT WITH THE SURGEON WHO WAS IN CONTACT WITH THE PATIENT'S OTHER PHYSICIAN. THE MANAGING HCP LATER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ACUTELY MANAGED/TREATED BY ANOTHER HCP. THE PUMP WAS SET TO A MINIMUM RATE. IT WAS NOTED THAT THE LAST REFILL AND EXAM DONE BY THE MANAGING HCP WAS (B)(6) 2012 AND WAS NORMAL. THE FILL WENT WELL, NO ISSUES AND NO ALARMS. THE ERI AT THAT TIME WAS 5 MONTHS AND A ROUTINE REPLACEMENT WAS SCHEDULED. THE PUMP DELIVERED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O