BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 3120352 · Received May 20, 2013

    Report

    Report Number
    3007566237-2013-01674
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8703W35, SERIAL# (B)(4), IMPLANTED/ EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THEY THOUGHT THERE WAS ¿AN ISSUE WITH THE PUMP¿. AS OF THE DATE OF THIS REPORT, IT WAS INDICATED THAT RIGHT NOW THEY WERE GOING TO TRY AND DO A DYE STUDY. REPORTER WAS ¿NOT TOO SURE RIGHT NOW, ABOUT PATIENT SYMPTOMS¿. IT WAS LATER REPORTED THAT PATIENT WAS IMPLANTED APPROXIMATELY IN 1998. HE HAD BEEN FOLLOWED BY A HEALTHCARE PROVIDER (HCP) IN (B)(6) SINCE 2000 AND WAS REFILLED THERE "EVERY 2 MONTHS OR SO". HE HAD A "POLYMIXTURE" IN HIS PUMP. ON (B)(6) 2013, HCP DETERMINED THAT HIS CATHETER WAS PATENT. REPORTER WAS UNAWARE HOW LONG HE WAS WITHOUT THERAPY AS HE WAS ON "HIGH DOSES OF NARCOTICS" BOTH PO/IV DURING HIS "HOSPITALIZATION". REPORTER HAD NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222371 ISOMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8472

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization