BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 4090199 · Received September 15, 2014

    Report

    Report Number
    3007566237-2014-02589
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (SN (B)(4)) WAS NOT ABLE TO PERFORM FLOW TESTING AS THE PUMP RAN DRY AFTER EXPLANT. THE PUMP WAS RECEIVED WITH THE PUMP OUTLET PORT UNCAPPED. NO FLOW COULD BE ESTABLISHED, DUE TO AN OCCLUDED CAPILLARY LINE. THE PUMP WAS NOT WITHIN THE SERIAL NUMBER RANGE THAT COULD PRODUCE A SEPTUM LEAK IF THE NEED WAS INSERTED AT THE EDGE OF THE RESERVOIR FILL PORT AND DEFLECTED OFF THE CHAMBER AREA. ANALYSIS DID PERFORM A TEST WITH A NEEDLE INSERTED AT THE EDGE OF THE RESERVOIR FILL PORT/SEPTUM AND DEFLECTED OFF OF THE CHAMBER AREA. NO LEAK WAS DETECTED. ANALYSIS WAS ALSO ABLE TO FILL/EMPTY THE PUMP WITHOUT ISSUE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT NEED ITB (INTRATHECAL BACLOFEN) THERAPY ANYMORE, "THE EPISODE WAS RECOGNIZED BECAUSE THE PATIENT CAME IN FOR A REFILL AND THE PUMP WAS EMPTY BEFORE THAT DAY". THE PATIENT HAD NO SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH FILLING DIFFICULTY. IT WAS STATED, "THE PUMP WAS EMPATI (EMPTY) BEFORE EXPECTED". THE HEALTHCARE PROFESSIONAL (HCP) THOUGHT IT WAS A POCKET FILL OR THE FILLING PORT HAD LEAKAGE. THE PUMP WAS EXPLANTED AND THEY WOULD BE TREATING THE PATIENT WITH ORAL ANTI-SPASTIC MEDICATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PATIENT WAS DESCRIBED AS "ALIVE - NO INJURY" AT THE TIME OF THE REPORT. THE PUMP WAS USED TO DELIVER LIORESAL (BACLOFEN). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568787 ISOMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8472-35-05

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Required Intervention