BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3612612 · Received February 7, 2014

    Report

    Report Number
    3004209178-2014-01730
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 19, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N173111, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID NEU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HAVING DEBILITATING BACK PAIN THAT IS SPREADING DOWN INTO THE LEG. IT WAS NOTED THAT THE PATIENT ENTERED A LOCAL HOSPITAL ON (B)(6) 2014, BECAUSE OF SEVERE BACK PAIN THAT WAS SPREADING DOWN INTO THE PATIENT¿S LEG. IT WAS REPORTED THAT THE PATIENT WAS TO HAVE A MRI ON (B)(6) 2014 TO ASSESS PINCHED NERVE. IT WAS NOTED THAT THE CALLER WAS ¿QUESTIONING IF THE PUMP IS STILL WORKING BECAUSE OF THE PAIN-ALTHOUGH THE PAIN CAME ON AGGRESSIVELY.¿ IT WAS REPORTED THAT AN X-RAY WAS DONE AND SHOWED NOTHING. IT WAS NOTED THAT THE HOSPITAL CONTACTED PATIENT¿S HEALTHCARE CLINIC TO COORDINATE A VISIT TO DETERMINE PUMP FUNCTION (FXN). IT WAS REPORTED THAT THE PATIENT DID NOT HAVE WITHDRAWAL SYMPTOMS OF THE MORPHINE BUT ¿IT WOULD BE DIFFICULT TO TELL SINCE PATIENT HAS RHEUMATOID ARTHRITIS AND IS ON SEVERAL ORAL MEDS FOR THAT AS WELL.¿ IT WAS NOTED THAT THE PATIENT RECENTLY USED A HEAT PAD ON LOW BACK AND RECEIVED A 4 INCH X 2 INCH BURN FROM THE PAD OPPOSITE SIDE OF THE PUMP. IT WAS REPORTED THAT THERE WAS NOTHING TO REPORT ON CHANGE OF SYMPTOMS. IT WAS NOTED THAT THE PATIENT¿S PUMP WAS USED TO INFUSE MORPHINE. IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER (HCP) ¿DID NOT KNOW¿ IF THE SCHEDULED MRI WAS RELATED. IT WAS NOTED THAT THE PATIENT WAS HAVING BACK PAIN AND THEY WERE HAVING TROUBLE CONTROLLING IT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PROBLEM WAS INCREASED PAIN. IT WAS LATER REPORTED PER THE PROGRESS NOTED DATED (B)(6) 2014 THAT THE PATIENT HAD BEEN IN THE HOSPITAL FOR THE PAST SEVERAL DAYS WITH INTRACTABLE BACK PAIN. SHE WAS RECEIVING VARIOUS INTRAVENOUS PAIN MEDICATIONS TO TRY AND CONTROL THE PAIN WITHOUT SUCCESS. THE PHYSICIAN WAS CONCERNED THAT THE PAIN PUMP MAY NOT BE FUNCTIONING PROPERLY. THE PATIENT WAS TRANSPORTED TO THE PAIN PHYSICIAN. SHE WAS ON A MORPHINE PCA AND WAS VERY SEDATED. SHE WAS RECEIVING OXYGEN AND APPEARED UNAWARE OF HER SURROUNDINGS. SHE WAS SLEEPING AND SLOW TO AROUSE. SHE DID RESPOND SLOWLY TO VERBAL QUESTIONS WITH PROMPTING. INTERROGATION OF THE PUMP FOUND IT TO BE WORKING PROPERLY. ON (B)(6) 2014 A CATHETER DYE STUDY WAS PERFORMED AND FOUND THAT THE CATHETER TIP WAS ABOVE T10. CONTRAST WAS SEEN WITHIN THE THECAL SAC AT T11 WHICH INDICATED THAT THE CATHETER WAS PATENT. THERE WAS SOME DENSE MATERIAL ABOUT THE CATHETER WITHIN THE SUBCUTANEOUS FAT WHICH COULD INDICATE LEAKAGE OF CONTRAST BUT COULD ALSO BE DUE TO CALCIUM DEPOSITION ABOUT THE CATHETER ESPECIALLY IN VIEW OF NUMEROUS OTHER CALCIUM DEPOSITS IN THE SUBCUTANEOUS FAT OF THE BUTTOCKS AND ADJACENT TO THE PAIN PUMP DEVICE. IT WAS NOTED THAT THERE WAS A TIGHTLY LOOPED SEGMENT OF CATHETER NEAR THE SPINE. THE DEVICE SYSTEM WAS USED TO DELIVER INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80106 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R