BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203561 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11210
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 24, 2013
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S PUMP ALARMED THE DAY BEFORE THE REPORTED EVENT AND THE DAY OF EVENT. IT WAS REPORTED THAT PATIENT¿S PUMP SHOULD HAD BEEN REFILLED ON (B)(6) 2013 AND THE PATIENT'S ALARM DATE SHOWED THE PUMP SHOULD HAVE BEEN OUT OF MEDICATION ON THE (B)(6). IT WAS NOTED THAT TELEMETRY WAS NOT YET PERFORMED AND THE PUMP STILL HAD MEDICATION IN IT. THE PATIENT WAS LOOKING FOR A NEW HEALTHCARE PROVIDER TO REFILL THE PUMP. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND STILL NEEDED TO TAKE ORAL MEDICATION. IT WAS NOTED THAT THE PATIENT HAD ORAL PAIN MEDICATION FOR USE. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE AND DILAUDID. IT WAS LATER REPORTED THAT THE PATIENT HAD CALLED BASIC HOME INFUSION (BHI) AND REQUESTED THAT THE DOCTOR REMOVE THE PUMP AS THE PUMP WAS DRY; HOWEVER, BHI DOES NOT LOOK FOR DOCTORS TO REMOVE THE PUMP, ONLY TO MANAGE THE PUMP. IT WAS LATER REPORTED THAT THE PUMP WAS REMOVED DUE TO THE PATIENT¿S RELOCATION AND INABILITY TO FIND A PAIN MANAGEMENT DOCTOR. THE PATIENT INDICATED THAT HER MEDICAL RECORDS WERE NOT TRANSFERRED TO HER NEW LOCATION. THE PATIENT EXPERIENCED WITHDRAWAL AND DELIRIUM TREMENS (DTS) FOR 2 WEEKS FOLLOWING THE MOVE AND LOST 25 POUNDS. THE PATIENT WEIGHED (B)(6) WHEN SHE MOVED AND AFTER WITHDRAWALS WEIGHED (B)(6). THE PATIENT INDICATED THAT SHE HAD AN APPOINTMENT DATE ON (B)(6) 2013 AND NO LONGER HAD CONCERNS WITH THE DEVICE OR THERAPY. IT WAS LATER REPORTED THAT THE PATIENT DID NOT LET THE MANAGING PHYSICIAN OR THE MANUFACTURER KNOW THAT SHE WAS MOVING. ONCE THE PATIENT MOVED HER PUMP WENT DRY AND SHE WENT THROUGH DETOXIFICATION AND ENDED UP IN THE HOSPITAL NUMEROUS TIMES. THE REPORTER STATED THAT THE PATIENT HAD LOST 30-40 POUNDS. THE PATIENT¿S PUMP HAD BEEN EXPLANTED WITHIN THE LAST 2 WEEKS PRIOR TO THE REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED ¿VARIOUS WITHDRAWAL SYMPTOMS¿. FOLLOWING THE EXPLANT, THE PATIENT WAS SEEKING A NEW PHYSICIAN TO MANAGE HER WITH ORAL PAIN MEDICATION BUT WAS HAVING DIFFICULTY FINDING A PHYSICIAN WHO ACCEPTS HER INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306447 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R