BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED NON-PROGRAMMABLE PUMP

    MDR report key: 2161972 · Received July 11, 2011

    Report

    Report Number
    3007566237-2011-05268
    Event Type
    Injury
    Date Received
    July 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CATHETER DILATATIONS WERE REPORTED INITIALLY. A CT SCAN OF THE PUMP AND CATHETER SHOWED 2 CATHETER DILATIONS. PATIENT WAS ASYMPTOMATIC. THE RESIDUAL VOLUME DURING REFILLS HAD MATCHED THE ACTUAL REMOVED VOLUME, BUT AT THE LAST REFILL, THERE WAS SOME DISCREPANCY. IT WAS LATER REPORTED THAT THIS WAS A 35ML PUMP WITH A FIXED FLOW OF 0.5ML/DAY. THE EXPECTED RESIDUAL VOLUME WAS 3.5 ML AND THE ACTUAL VOLUME, ACCORDING TO THE HCP WAS USUALLY 7-8 ML. PUMP REFILLS HAPPENED EVERY 9 WEEKS WITH A 2000 MICROGRAMS/ML BACLOFEN (LIORESAL) AND COMPOUNDED 4% BUPIVACAINE ADMIXTURE. DEPENDING ON THE DOSE OF BOTH DRUGS, SALINE WAS ADDED IN THE REQUIRED AMOUNT. PUMP WAS REPLACED BY A 60ML ARCHIMEDES PUMP, WITH A FLOW OF 0.8 ML/DAY. WHEN REPLACING THE PUMP, IT WAS CONFIRMED THAT THE CATHETER WAS PERMEABLE: THEY ASPIRATED MEDICATION AND CSF AND THEN SALINE SOLUTION WAS INFUSED WITHOUT FINDING RESISTANCE. CATHETER WAS THEREFORE LEFT IN PLACE; THE CONNECTION BETWEEN CATHETER AND THE PUMP WAS PERFECT. THE PUMP PORT SEPTUM APPEARED NORMAL AND HAD NO LEAKS. THE EXTERNAL APPEARANCE OF THE PUMP WAS NORMAL. THE PATIENT HAD WELL CONTROLLED PAIN AND SPASTICITY, AND WAS STILL RECEIVING THE SAME DOSE OF BOTH DRUGS HE WAS RECEIVING PREVIOUSLY I.E. 430 MICROGRAMS/DAY OF BACLOFEN AND 10 MG/DAY BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED NON-PROGRAMMABLE PUMP LKK MEDTRONIC NEUROMODULATION 8472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# UNKNOWN