BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 5042145 · Received August 31, 2015

    Report

    Report Number
    6000030-2015-00117
    Event Type
    Death
    Date Received
    August 31, 2015
    Report Date
    August 18, 2015
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNKNOWN; INDICATED DATE IS EARLIEST POSSIBLE ESTIMATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J11018R31, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PREVIOUSLY SUBMITTED NOTIFIED DATE OF 2015-08-18 WAS INCORRECT AND SHOULD HAVE BEEN NOTED AS 2015-08-26, THE DATE THE NEW INFORMATION MADE THE EVENT A REPORTABLE COMPLAINT. CORRECTION: THE PREVIOUSLY SUBMITTED STATEMENT: "ADDITIONAL INFORMATION CONFIRMING THE CAUSE OF DEATH WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE ADDED TO THE REPORT," WAS CORRECTED TO "NO FOLLOW-UP WAS ABLE TO BE REQUESTED AS THERE WAS NO CONTACT INFORMATION FOR THE INITIAL REPORTER, AND THE HCP INDICATED THAT THEY HAD NO FURTHER INFORMATION DUE TO DESTRUCTION OF RECORDS RELATED TO HURRICANE RITA." CORRECTION: THE PREVIOUSLY SUBMITTED NOTIFIED DATE OF 2015-08-18 WAS INCORRECT AND SHOULD HAVE BEEN NOTED AS 2015-08-26, THE DATE THE NEW INFORMATION MADE THE EVENT A REPORTABLE COMPLAINT.

    Description of Event or Problem · 1

    ON 2015-08-18, INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (CONCENTRATION, DOSE, LOT NUMBER, AND DATES OF THERAPY UNKNOWN) VIA AN IMPLANTABLE PUMP. INDICATIONS FOR USE INCLUDED INTRACTABLE SPASTICITY AND HEAD/BRAIN INJURY. CONCOMITANT MEDICATIONS AND THE PATIENT'S MEDICAL HISTORY WERE NOT PROVIDED. ACCORDING TO THE BROTHER OF THE PATIENT, THE PATIENT HAD THEIR DEVICE REMOVED IN 2005, PRIOR TO THEIR PASSING WAY (SEE MANUFACTURER'S REPORT NUMBER 6000030-2015-00109 FOR DEVICE REMOVAL); THE DATE OF DEATH WAS UNKNOWN, AS WAS THE DATE, FACILITY, OR PHYSICIAN THAT REMOVED THE DEVICE. ON 2015-08-26, ADDITIONAL INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP) AT THE OFFICE OF THE IMPLANTING PHYSICIAN. THE HCP STATED THAT THEY HAD LOST TRACK OF THE PATIENT, DUE TO EVACUATION OF THE FACILITY IN (B)(6) OF 2005 BECAUSE OF HURRICANE (B)(6). THE EVACUATION TOOK PLACE CLOSE TO A TIME WHEN THE PATIENT NEEDED TO BE REFILLED. ACCORDING TO THE HCP, THE FAMILY HAD TRIED TO GET SOMEONE TO PAY ATTENTION TO THE FACT THAT THE PATIENT WAS GOING INTO WITHDRAWAL, BUT THERE WAS SO MUCH CHAOS AT THE TIME, THAT THEY JUST WEREN'T HEARD. THE HCP STATED THAT IT WAS SUSPECTED BY THE PATIENT'S FAMILY THAT THE PATIENT DIED DUE TO COMPLICATIONS RELATED TO BACLOFEN WITHDRAWAL; THAT WAS NEVER CONFIRMED, AS AN AUTOPSY WAS NEVER PERFORMED. THE HCP WAS UNABLE TO PROVIDE FURTHER INFORMATION REGARDING THE BACLOFEN, AS THE PAPER RECORDS WERE DESTROYED DURING THE HURRICANE. THE HCP COULD NOT PROVIDE MEDICAL RECORDS OR A DEATH CERTIFICATE, AS THE DID NOT HAVE ANYTHING. ADDITIONAL INFORMATION CONFIRMING THE CAUSE OF DEATH WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE ADDED TO THE REPORT.

    Description of Event or Problem · 1

    NO FOLLOW-UP WAS ABLE TO BE REQUESTED AS THERE WAS NO CONTACT INFORMATION FOR THE INITIAL REPORTER, AND THE HCP INDICATED THAT THEY HAD NO FURTHER INFORMATION DUE TO DESTRUCTION OF RECORDS RELATED TO HURRICANE RITA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575133 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Death| O