BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCRHOMED EL

    MDR report key: 1715106 · Received June 8, 2010

    Report

    Report Number
    6000030-2010-04619
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    February 20, 2005
    Report Date
    May 12, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1147-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PATIENT FELL. A MYELOGRAM WITH CONTRAST SHOWED A COMPLETE BLOCKAGE OF SPINAL FLUID AT THE T-12 LEVEL OF THE PATIENT'S SPINE. A GRANULOMA WAS NOTED THAT MAY HAVE FORMED AROUND THE PATIENT'S CATHETER TIP. THE PUMP, CATHETER AND MOST OF THE GRANULOMA WERE REMOVED ON (B) (6) 2005 AND WAS EFFECTIVE IN DECOMPRESSING THE PATIENT'S SPINAL CORD. IT WAS STATED THAT THE PATIENT "WAS PERMANENTLY RENDERED A PARAPLEGIC." THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, ON APPROXIMATELY (B)(6) 2005, THE PATIENT FELL AT HIS HOME. THE PATIENT WAS TAKEN BY AMBULANCE TO THE EMERGENCY ROOM (ER), WHERE THE PATIENT REPORTED FEELING HEAVINESS AND DECREASED SENSATION, ¿LIKE A ROCK¿, IN HIS RIGHT LEG. THE PATIENT ALSO HAD DIFFICULTY URINATING, WHICH HAD WORSENED OVER THE PREVIOUS 3 DAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DIAGNOSTIC TESTING AND FOLLOW-UP CARE. THE FOLLOWING TWO DAYS, THE PATIENT WAS EVALUATED BY THE NEUROSURGEON, WHO WAS NOT INFORMED THAT THE PATIENT¿S PUMP COULD CAUSE A GRANULOMA AT THE CATHETER TIP. THE NEUROSURGEON THEREFORE DID NOT INCLUDE THE POSSIBILITY THAT THE PATIENT WAS SUFFERING FROM A GRANULOMA IN HIS DIFFERENTIAL DIAGNOSIS AND DID NOT ORDER IMAGING TESTS WITH CONTRAST THAT WOULD HAVE REVEALED THE SOFT TISSUE MASS THAT WAS CAUSING THE PATIENT¿S NEUROLOGICAL SYMPTOMS. ON (B)(6) 2005, THE PATIENT WAS EVALUATED BY A DIFFERENT HEALTHCARE PROVIDER (HCP), WHO NOTED THAT THE PATIENT HAD ASCENDING PARALYSIS IN BOTH LOWER EXTREMITIES. THIS HCP¿S DIFFERENTIAL DIAGNOSIS INCLUDED THE POSSIBILITY THAT A GRANULOMA MAY HAVE FORMED AROUND THE CATHETER TIP. THE HCP ORDERED A CT MYELOGRAM WITH CONTRAST IN ORDER TO EXPLORE THAT POSSIBILITY. THE RESULTS OF THE CT INDICATED THAT THE PATIENT WAS EXPERIENCING A COMPLETE BLOCKAGE OF SPINAL FLUID AT THE T12 LEVEL, CAUSED BY A GRANULOMA THAT HAD FORMED AT THE CATHETER TIP. THE FOLLOWING DAY, THE PATIENT¿S ¿HARDWARE¿ AND MOST OF THE GRANULOMA WERE SURGICALLY REMOVED FROM THE PATIENT¿S BACK, WHICH RESULTED IN EFFECTIVE DECOMPRESSION OF THE PATIENT¿S SPINAL CORD. DESPITE THIS SURGICAL DECOMPRESSION, THE PRIOR COMPRESSION FROM THE GRANULOMA HAD ALREADY PERMANENTLY DAMAGED THE PATIENT¿S SPINAL CORD SO THAT HE BECAME PERMANENTLY PARAPLEGIC. THE PARAPLEGIC MADE THE PATIENT HIGHLY SUSCEPTIBLE TO THE FORMATION OF DECUBITUS ULCERS. IN 2013, THE PATIENT DEVELOPED A DECUBITUS ULCER THAT RESULTED IN WIDESPREAD SEPSIS, WHICH WAS THE CAUSE OF THE PATIENT¿S DEATH ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| L| R| S EXPLANTED:| IMPLANTED,| CATHETER: MODEL 8711, LOT# L78414