Device Recall Synchromed II

Manufacturer

  • Manufacturer Address
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    All SynchroMed EL and SynchroMed II pumps
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
  • Product Description
    Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
  • Manufacturer
  • Model / Serial
    all SynchroMed EL pumps
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. || Product Usage: || The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. || The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.
  • Manufacturer
  • Model / Serial
    all SynchroMed II pumps
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide
  • Product Description
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories || The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:
  • Manufacturer
  • Model / Serial
    This Medical Device Correction notification affects all SynchroMed II pumps.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - All states in USA. OUS: List not provided at this time.
  • Product Description
    Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. || The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
  • Manufacturer
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