BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2902878 · Received January 9, 2013

    Report

    Report Number
    6000030-2013-00005
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO UPDATE/CORRECT CONCLUSION CODES. ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS DUE TO HAVE A NEW PUMP IMPLANTED IN (B)(6) 2011, BUT THE HEALTHCARE PROVIDER (HCP) DECIDED TO WAIT UNTIL AFTER THE HOLIDAYS TO REPLACE THE PUMP. ON (B)(6) 2012, THE PATIENT WAS IN A CAR ACCIDENT. FOLLOWING THE CAR ACCIDENT, THE PATIENT WENT TO THE HOSPITAL AND HE TOLD THEM SOMETHING FELT WRONG. ABOUT 5 DAYS WENT BY AND DURING THAT TIME THE PATIENT HAD CALLED THE HCP'S OFFICE A COUPLE OF TIMES TO TELL THEM SOMETHING DIDN'T FEEL RIGHT. BY THE 5TH DAY, THE PATIENT WAS GETTING "SO SICK TO HIS STOMACH THAT HE THOUGHT HE WAS DYING." HE WENT IN TO THE CLINIC AND THEY SHUT THE PUMP OFF COMPLETELY. THE PUMP HAD COME "UNHOOKED" AS A RESULT OF THE CAR ACCIDENT. THE PATIENT WASN'T GIVEN ANY MEDICATION FOR OVER THE WEEKEND; THE HCP SAID HE'D BE FINE AND HE'D TAKE CARE OF IT MONDAY MORNING. MONDAY MORNING CAME AND THE PATIENT WASN'T GIVEN ANY MEDICATION. HE WAITED 4 OR 5 DAYS AND HE COULDN'T GET THEM TO PRESCRIBE HIM ANYTHING, SO HE SAW ANOTHER PHYSICIAN AND WAS GIVEN "SOME HEAVY MORPHINES." THE PUMP WAS EVENTUALLY REPLACED. THE PATIENT WAS UPSET BY THE LOOK OF THE SCAR THAT WAS LEFT FOLLOWING THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10923 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention