BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3961901 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13612
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    September 12, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ID 8782 SERIAL # (B)(4) EXPLANTED: (B)(6) 2014. ADDITIONAL INFORMATION: (B)(4). ADDITIONAL INFORMATION/DEVICE EVALUATION: THE SPINAL SEGMENT OF THE CATHETER AND ANCHOR WERE RETURNED FOR ANALYSIS. ANALYSIS OR THE CATHETER REVEALED NO SIGNIFICANT ANOMALY - ¿DRIED DRUG, BLOOD, OR FOREIGN MATERIAL OCCLUSION.¿ ANALYSIS OF THE ANCHOR REVEALED NO SIGNIFICANT ANOMALY ¿ ¿ANCHOR DID NOT PROPERLY DETACH FROM TOOL ¿ STILL ABLE TO USE.¿

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8782, SERIAL # (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL # (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8835, SERIAL (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8782, SERIAL (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8784, SERIAL (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDERDOSE SYMPTOMS WITH LESS THAN 50% THERAPY RELIEF. A DYE STUDY WAS DONE; THE DATE WAS NOT REPORTED. THE DISTAL SEGMENT OF THE CATHETER HAD MIGRATED/DISLODGED. THEY OPENED THE SPINAL INCISION TO ASSESS THE CATHETER. THE ANCHOR WAS INTACT AND TIED DOWN HOWEVER IT APPEARED THAT PART OF THE ANCHOR THAT SHOULD HAVE BEEN IN THE FASCIA HAD ROLLED IN ON ITSELF. THE SPINAL SEGMENT OF CATHETER HAD PULLED COMPLETELY OUT OF INTRATHECAL SPACE AND WAS INTACT BUT COILED IN THE SPINAL POCKET. A NEW SPINAL SEGMENT AND NEW ANCHOR WERE IMPLANTED AND THEN CONNECTED TO EXISTING PROXIMAL SEGMENT. BEFORE CONNECTING, THE PHYSICIAN ACCESSED THE CAP (CATHETER ACCESS PORT) AND FLUSHED WITH NORMAL SALINE AND IT SHOWED THE PROXIMAL SEGMENT WAS PATENT. THE PUMP STILL CONTAINED SALINE. THE PUMP WAS GOING TO BE REFILLED AT THE PHYSICIAN¿S OFFICE THE WEEK AFTER THE CATHETER REVISION. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS VERY DISPLEASED WITH THE IMPLANTED PUMP COMPARED TO THE TRIAL PUMP. THE PHYSICIAN STILL HAD THE PATIENT ON A ¿GOOD AMOUNT¿ OF ORAL MEDS DURING THE TRIAL AND THEN WHEN THE PATIENT RECEIVED THE IMPLANT, THE ORAL DRUGS WERE TAKEN AWAY AND ¿NOT EVEN CALCULATED INTO THE AMOUNT DELIVERED¿. AS OF (B)(6) 2014, THE PATIENT WAS GOING THROUGH MAJOR WITHDRAWALS. IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HIS DEVICE OR THERAPY, BUT WAS WORKING WITH HIS HCP (HEALTHCARE PROVIDER). HIS NEXT APPOINTMENT WAS (B)(6) 2014. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE DEVICE SYSTEM WAS DELIVERING MORPHINE AND CLONIDINE. THE PATIENT WAS EXPERIENCING WITHDRAWAL AND PAIN; THE PATIENT HAD PAIN AT OR NEAR HIS RIBS. A PUMP AND CATHETER STUDY WERE PLANNED. PRIOR TO THE SCAN THEY ¿COULD NOT DRAW.¿ NORMAL SALINE WAS PLACED IN THE PUMP. IT WAS NOTED THAT THERE WERE ¿APPARENTLY NO KINKS, NO LEAKS.¿ THE ISSUE WAS NOT RESOLVED. THE PATIENT HAD TO DECIDE IF HE WANTED A REVISION. THE PATIENT WAS BEING MANAGED WITH ORAL MEDICATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT VIA A MEDWATCH FORM ON 2017-SEP-08. THE PATIENT STATED THEY HAD A PAIN PUMP INSTALLED ¿8 MONTHS PRIOR TO THE DATE LISTED¿ ((B)(6) 2015 AS IMPLANT AND (B)(6) 2015 AS EXPLANT). IT WAS REPORTED THAT AFTER MANY MONTHS OF THE SURGEONS TRYING TO FIGURE OUT THE PUMP PROBLEM, THE PATIENT HAD THEM EXPLANT THE DEVICE. SINCE EXPLANT, THE PATIENT HAD SEVERE PAIN BELOW THE SURGICAL SITE. WHEN THE PATIENT WAS QUESTIONING THE SURGEON AND THE NURSES, THE PATIENT WAS LET GO FROM THE CLINIC. THE ISSUE WAS YET TO BE RESOLVED AND THE PATIENT FELT ABANDONED BY THE DOCTORS. THE PATIENT ALSO REPORTED THAT THE DOCTOR INFECTED THE PATIENT¿S SPINE DURING A ROUTINE DISCO GRAM WHICH LED TO CHRONIC PAIN FROM CERVICAL FUSION. C2 THROUGH C7 WITH INSTRUMENTATION. MULTIPLE LOWER BACK SURGERIES WERE REPORTED SINCE THE EVENT. THERE WAS ALSO ROTATOR CUFF SURGERY, LITHOTRIPSY ON BOTH KIDNEYS, AND A NON-RADIO OPAQUE CATHETER WAS LEFT IN THE SPINE AFTER THE PAIN PUMP REMOVAL. OVER THE COUNTER MEDICATIONS WERE REPORTED AS PROTEIN, MULTIVITAMINS, AND VITAMIN C CAPSULES. THE EVENT OUTCOME WAS LISTED AS ¿DISABILITY/PERMANENT DAMAGE.¿ THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED NO PART OF THE 8782 CATHETER WAS LEFT IN THE INTRATHECAL SPACE. AT THE TIME OF THE REPORT IT WAS NOT KNOWN HOW THE PATIENT WAS DOING AS THE REPORTER HAD NOT BEEN ABLE TO FOLLOW UP WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437611 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention