BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242583 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12153
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿SICK IN THE HOSPITAL,¿ THAT SHE FIRST WENT IN ON (B)(6) 2013, AT WHICH TIME ¿THEY CHECKED HER PUMP,¿ AND ¿THEY SAID IT WAS WORKING¿ BUT THAT SHE ¿NEEDED TO DO A STUDY TO SEE IF THERE WERE ANY KINKS.¿IT WAS NOTED THAT THE PATIENT WAS LEAVING ON A CRUISE AND CONTACTED HER HEALTHCARE PROVIDER (HCP) WHEN SHE RETURNED, AND HER HCP WANTED TO DO A ROTOR STUDY. IT WAS STATED ¿THIS SUNDAY WAS A WEEK AGO [THE PATIENT] WAS REAL WITH THE SAME SYMPTOMS.¿ SO ¿THEY UPPED¿ HER DOSE TO TAKE ORALLY OF DILAUDID, NOTING SHE WAS ON 4MG EVERY 4 HOURS ¿UNTIL THE DO THIS STUDY.¿ THE SYMPTOMS THE PATIENT EXPERIENCED WERE NOTED AS THE PATIENT¿S BACK WAS HURTING ¿NATURALLY,¿ SHE FELT SHE HAD NO STRENGTH LEFT IN HER BODY, IT WAS HARD FOR HER TO WALK FROM HER BED ROOM TO THE LIVING ROOM. IT WAS LIKE SHE ¿WAS FADING AWAY,¿ HER VOICE WAS EXTREMELY WEAK, SHE ¿COULDN¿T FIX [HERSELF] ANYTHING TO EAT OR ANYTHING LIKE THAT IF [SHE] WANTED TO,¿ SHE FELT SO VERY DEATHLY ILL. GOT NAUSEATED, NOTHING WOULD STAY IN, THEN ¿IT WAS LIKE A DIARRHEA BUT IT'S NOT LIKE NORMAL DIARRHEA,¿ ¿IT WOULD BURN AFTERWARDS.¿ HER ¿SENSE OF SMELL THAT EVERYTHING WAS JUST HEIGHTENED,¿ SHE FELT HER BODY ¿STUNK¿ AND KNEW THAT IT DIDN¿T, FRAGRANCE WAS ¿JUST MAGNIFIED IN THE WAY IT SMELLED.¿ SHE WAS KEPT OVERNIGHT, WAS GIVEN IV, ALTHOUGH IT WAS NOT REPORTED WHAT MEDICATION WAS ADMINISTERED VIA IV. IT WAS NOTED THAT HER POTASSIUM WAS ¿ROCK BOTTOM¿ ¿LIKE 3¿ SHE THOUGHT. THE PATIENT WAS GIVEN 2 ¿LARGE DOSES OF DILAUDID,¿ ¿DOSED RIGHT OFF TO SLEEP¿ AND WHEN SHE WOKE UP SHE ¿IMMEDIATELY¿ KNEW SHE WAS BETTER.¿ THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER LATER REPORTED THAT A CATHETER DYE STUDY AND PUMP ROTOR STUDY WAS PERFORMED ON (B)(6) 2013. THE RESULTS WERE NORMAL. THE PATIENT HAD INCREASED PAIN AND A ¿STRANGE TASTE.¿ THE PATIENT RECOVERED WITHOUT SEQUELAE, AND IT WAS NOTED THAT THEY DID NOT REQUIRE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342731 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R