BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2770297 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08830
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ATTORNEY ALLEGES A RECURRING FAILURE OF THE PAIN PUMP AND INTRATHECAL CATHETER. THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC RELIEF AND 3 PUMP REVISION/CATHETER REPLACEMENTS WERE PERFORMED. IT WAS REPORTED ON (B)(6) 2010, THE PATIENT SUFFERED A PULLOUT OF A PREVIOUSLY INTRATHECAL CATHETER. X-RAY CONFIRMED THE CATHETER DISLODGEMENT AND FOUND CATHETER TO BE COILED INTO THE SUBCUTANEOUS POCKET WITH THE PUMP, OVER THE ABDOMEN. A NEW CATHETER WAS INSERTED AT L2-3 AND SECURED AT THAT TIME. IT WAS LATER REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT ANOTHER PUMP REVISION AND CATHETER REPLACEMENT. THE PATIENT REPORTED HAVING NO PAIN RELIEF. THE HEALTHCARE PROVIDER (HCP) USED FLUOROSCOPY TO IDENTIFY THE CATHETER, HOWEVER WAS UNABLE. AS THE HCP WAS UNABLE TO IDENTIFY THE CATHETER, THE HCP ELECTED TO MAKE A MIDLINE INCISION OVER THE CATHETER AND EXPLORE FOR IT. THE HCP FURTHER DESCRIBED BEING UNABLE TO ACCESS THE OLD CATHETER, SO IT WAS REMOVED AND REPLACED. IT WAS ALSO NOTED AT THAT TIME, THAT THERE WAS MALPOSITION OF THE PUMP AS IT HAD REPEATEDLY FLIPPED. IT WAS THEN LATER REPORTED THAT THE PATIENT HAD TWO ADMISSIONS TO THE EMERGENCY ROOM (ER) FOR BACK PAIN. THE SECOND OF THE VISITS WAS ON (B)(6) 2011 WHERE THE PATIENT WAS SEEN FOR A RETURN OF SYMPTOMS (PAIN), AT WHICH TIME THE PATIENT ALLEGED THE 'MORPHINE PUMP NOT WORKING'. THE PATIENT HAD FALLEN 6 DAYS PRIOR (APPROX. (B)(6) 20111) FOLLOWING AN ASSAULT. AS OF (B)(6) 2011, THE PATIENT REPORTED THAT THE 'PAIN PUMP AND BACK REPORTEDLY NOW WORKING' AND HAD NORMAL X-RAYS. IT WAS TWO DAYS LATER ON (B)(6) 2011 THAT THE PATIENT REPORTED A CHANGE IN THERAPEUTIC EFFECT AND SWELLING AT THE PUMP SITE FOLLOWING THE FALL. WITHIN A FEW DAYS OF THE FALL, THE PATIENT NOTICED THAT THERE WAS 'ABSOLUTELY NO PAIN RELIEF' WHEN THE PATIENT PREVIOUSLY HAD 'EXCELLENT RELIEF OF PAIN'. DIAGNOSTIC X-RAY SHOWED NO GROSS DISLODGEMENT OF THE CATHETER. A SIDE PORT MYELOGRAM WAS PERFORMED, WHICH SHOWED FREE FLOW OF THE CONTRAST SUBCUTANEOUSLY AT THE SITE OF THE LIGAMENT AND THE PATIENT WAS DETERMINED TO HAVE A FRACTURED CATHETER. THE PATIENT THEN UNDERWENT A PUMP REVISION AND CATHETER REPLACEMENT ON (B)(6) 2011 TO REPLACE THE FRACTURED CATHETER. THE HCP REPORTED A POST-OPERATIVE DIAGNOSIS OF 'FRACTURED INTRATHECAL CATHETER', FOLLOWING THE ASSAULT IN (B)(6) 2011. SPECIFIC IDENTIFICATION MARKERS (I.E. SERIAL/LOT #) WERE NOT PROVIDED FOR THE REVISED AND NEWLY IMPLANTED CATHETERS. THE MEDICATION IN THE PUMP WAS INFUMORPH (MORPHINE). A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention