BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 4998244 · Received August 12, 2015

    Report

    Report Number
    3004209178-2015-15913
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015,: PRODUCT TYPE: PUMP. PRODUCT ID: 8590-1, LOT# N132989, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8 590-1, LOT# N132989, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE ACTUAL RESERVOIR VOLUME HAD BEEN 10CC GREATER THAN EXPECTED AT THE PRIOR TWO REFILLS, AND THE PATIENT WAS HAVING INCREASED PAIN. THE PUMP PROGRAMMED TO DELIVER DILAUDID [10MG/ML] WITH A DOSE OF 2.3MG. AN X-RAY WAS PERFORMED, AND NO KINK WAS SEEN IN THE CATHETER. THE PUMP LOGS WERE READ, AND THERE WERE NO MOTOR STALLS. AS OF (B)(6) 2016, THERE WAS NO PATIENT INJURY; HOWEVER, SURGICAL INTERVENTION WAS SCHEDULED FOR (B)(6) 2016. THE OLD CATHETER WAS REPLACED, AND THEY GOT GOOD CEREBROSPINAL FLUID FLOW.

    Description of Event or Problem · 1

    ON (B)(6) 2015, INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING DILAUDID 10MG/ML AND BUPIVACAINE 20MG/ML AT 1.998 MG/DAY VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. ON (B)(6) 2015, THE PATIENT EXPERIENCED UNDERINFUSION. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 2 AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 13. IT WAS UNKNOWN IF IT WAS DUE TO A PROGRAMMING ERROR. THE HCP BELIEVED THAT 20ML WAS INJECTED AT THE RECENT PUMP REPLACEMENT. THE HCP THEN INJECTED 10ML OF SALINE AND ASPIRATED SUCCESSFULLY TO CONFIRM ALL FLUID WAS ASPIRATED. THE PUMP WAS THEN REFILLED SUCCESSFULLY WITH 40ML. THE HCP PLANNED TO MONITOR THE PATIENT FOR SYMPTOMS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530479 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8709SC

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention