BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2851724 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10965
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 4, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: UNK; PROGRAMMER MODEL: 8835, SERIAL# (B)(4). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE CATHETER REPLACED ON (B)(6) 2012 BECAUSE THE CATHETER WAS BROKEN. THE PUMP POCKET AND THE SPINE WERE ACCESSED DURING REVISION. DRUG DELIVERED VIA THE DEVICE CURRENTLY WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT WHEN THE CATHETER WAS REVISED THEY COULDN¿T GET PART OF IT OUT OF THE PATIENT¿S SPINE. APPROXIMATELY 3 MONTHS PRIOR TO THE CATHETER REVISION, THE PHYSICIAN HAD UPPED THE PATIENT¿S MEDICATION ¿A PRETTY GOOD BIT¿. WHEN HE WENT BACK IN THE NEXT WEEK, HE TOLD THE PHYSICIAN THAT IT FELT LIKE HE ¿WENT BACKWARDS INSTEAD OF FORWARDS¿. THE PHYSICIAN HAD THE PATIENT COME BACK IN A COUPLE OF WEEKS LATER AND ADJUSTED THE MEDICATION UP AGAIN. THE PATIENT WAS STILL GETTING WORSE. THE THIRD TIME THE PATIENT TOLD THE PHYSICIAN HE WAS GETTING WORSE, THE PHYSICIAN SENT HIM TO THE HOSPITAL AND THEY RAN A SCAN AND DETERMINED THAT THE CATHETER WAS BROKEN. TWO WEEKS AFTER THE CATHETER REVISION, THE PATIENT DEVELOPED A STAPH INFECTION AND THE SYSTEM WAS REMOVED. IT WAS THOUGHT THAT THE PATIENT CAUGHT THE STAPH INFECTION IN THE HOSPITAL. THE PATIENT HAD TO WAIT 3 MONTHS TO BE RE-IMPLANTED. HE STATED THAT HE WAS IN SO MUCH PAIN THAT HE HAD ¿JUST ABOUT ASSUMED OF BEING DEAD¿. A NEW SYSTEM WAS IMPLANTED IN (B)(6) 2013.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention