BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4120747 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17773
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N303824, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID; 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEY ARE GOING TO SEE THE HCP THE DAY OF THE REPORT ABOUT A FIFTH SURGERY ON THEIR BACK. THE PATIENT STATED IF HE WAS GOING TO WALK FROM HIS BED TO THE BATHROOM WHICH IS FIVE STEPS, THE PATIENT HAD TO HAVE ANOTHER SURGERY. THE PATIENT STATED THE SURGERY WAS RELATED TO THEIR DEVICE. THE PATIENT¿S PUMP NEEDED TO BE TURNED UP AGAIN AND PER THE PATIENT THE HCP WAS WORRIED ABOUT IT MAKING THE PATIENT DROWSY OR WHATEVER AND ABOUT HOW HIGH THE HCP MAY WANT TO TURN THE PUMP UP. THE PATIENT HAD HAD TWO SURGERIES ON HIS NECK AND UPCOMING SURGERY WILL BE THIRD ON LOWER BACK FOR A TOTAL OF FIVE SURGERIES TO HELP THE PATIENT WALK. IT WAS DIFFICULT FOR THE PATIENT TO WALK FROM BED TO BATHROOM AND WHEELCHAIR TO VAN WHICH IS APPROXIMATELY FIVE STEPS.. THE PATIENT STATED THE PUMP WAS STILL COVERING THEIR PAIN BUT NEEDED TO BE TURNED UP, AND STATED ¿HOW FAR DOES THE HCP WANT TO TURN IT UP¿. PER THE PATIENT THEY CAN STAND ANOTHER ONE OR TWO INCREASES BUT CAN¿T GET BY WITHOUT ANOTHER SURGERY AND HAS TO GET SURGERY. PER THE PATIENT IT WAS NOT A NEW PAIN BUT GRADUALLY GETTING WORSE. THE PATIENT HAD BEEN ON PILLS OR SOME KIND OF PAIN RELIEVER FOR SEVERAL YEARS STATING HE BROKE HIS BACK (B)(6) 1965. THE PUMP WAS USED TO DELIVER DILAUDID. THE INTERVENTIONS AND PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THE INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602018 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention