BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2676224 · Received July 31, 2012

    Report

    Report Number
    3007566237-2012-01812
    Event Type
    Injury
    Date Received
    July 31, 2012
    Report Date
    July 3, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8832, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE. PROGRAMMER, PATIENT PRODUCT ID 8709SC, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYPE. CATHETER PRODUCT ID 8709, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID 8590-1, LOT# N124717, SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYP ACCESSORY PRODUCT ID 8578, LOT# N120298, SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD PUMP REFILL ON TUESDAY (B)(6) AND THE HEALTH CARE PROFESSIONAL (HCP) INCREASED MEDICATION FROM 55MCG TO 75MCG OF FENTANYL. IT WAS ON FRIDAY THAT THE PATIENT HAD EXPERIENCED WITHDRAWAL SYMPTOMS. IT WAS NOTED THAT PATIENT FELT "THE SHAKES, STOMACH ISSUES AND THAT HIS COLON WAS TIED IN A KNOT". THAT FOLLOWING MONDAY, (B)(6) 2012, HIS HCP GAVE HIM 2 BOLUSES AND HE FELT BETTER ALMOST INSTANTLY. ON THE DAY OF THIS REPORT, THE PATIENT EXPERIENCED WITHDRAWALS AGAIN. IN ORDER TO GET THE PUMP HE HAD TO GO OFF HIS ORAL METHADONE AND HE HAD HORRIBLE WITHDRAWALS, "48 HOURS WHERE HE COULD NOT SLEEP AND HE LOST (B)(6)". IT WAS UNCLEAR IF THESE SYMPTOMS WERE RELATED TO THE EVENT OR NOT. IT WAS NOTED THAT PATIENT HAD AN APPOINTMENT WITH HIS HCP SCHEDULED ON THE DATE OF THIS REPORT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R