BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1051762 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02693
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    January 1, 2006
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOR 19 MONTHS, THE PATIENT EXPERIENCED PAIN UNDER HER RIBS AND PAIN ON HER SKIN WHICH WAS LIKE SHINGLES. THE PATIENT HAD AN MRI (DATE NOT REPORTED) AND A TUMOR WAS FOUND ON HER THORACIC SPINE. AFTER SURGERY, THE PATIENT WAS TOLD IT WAS CRYSTALIZED MORPHINE. THE PATIENT WAS AT HOME. HER STATUS WAS REPORTED AS "FAIR". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT "MORPHINE WAS COMING OUT" OF THE CATHETER AND THAT A GRANULOMA RESULTED. REPORTER STATED THAT SHE FELL 16 TIMES DURING (B)(6) 2011 AND THAT HER LOWER BACK HAD BEEN "MESSED UP" SINCE. IT WAS INDICATED THAT THE HEALTH CARE PROVIDER (HCP) WANTED TO DO A MAGNETIC RESONANCE IMAGING (MRI) SCAN FOR THE GRANULOMA AND THE BACK ISSUES. IT WAS UNCLEAR IF THE MRI HAD OCCURRED AND THE GRANULOMA WAS PRESENT, AS IT WAS PREVIOUSLY INDICATED THAT THE PATIENT HAD AN MRI AND SURGERY FOR THE GRANULOMA. REPORTER ALSO STATED THAT SHE HAD SORE SKIN, A COMPRESSED NERVE ROOT WHICH HAD CAUSED HER PAIN FROM HER BREAST AREA TO HER WAIST AND TIGHTNESS WHEN SHE WOULD USE HER ARMS. IT WAS INDICATED IF THE HCP WERE TO "STRIP" THE PATIENT'S NERVE, THAT SHE WOULD BE PARAPLEGIC. IT WAS REPORTED THAT THE PATIENT WAS ON BY MOUTH OXYCONTIN FOR HER COMPRESSED NERVE FROM HER FAMILY HCP; HOWEVER THE MANAGING PUMP HCP STOPPED THE MEDICATION. IT WAS INDICATED THAT THE MANAGING PUMP HCP STATED THAT THE PATIENT WOULD DIE IF SHE CONTINUED TAKING OXYCONTIN ALONG WITH THE MORPHINE THAT WAS IN HER PUMP. REPORTER STATED THAT SHE TAKES EIGHT, 500 MG OF TYLENOL PILLS PER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MANUFACTURING 8709 J12538R17

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R EXPLANTED| PUMP: MODEL 863720| PROGRAMMER: MODEL 8840| IMPLANTED