PROMETRA® II PROGRAMMABLE PUMP
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electrohydraulic lithotriptors, has not been tested on the Prometra II pump. If lithotripsy must be
used, do not focus the beam in proximity of the pump.
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Medical devices
. The Prometra Programmer may affect other medical devices. Use or interference
with medical devices, other than neurostimulators, has not been established.
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Applied electric currents.
Interaction of the Prometra II Pump with electric currents applied to the
body such as cardioversion or defibrillation has not been established. Care must be exercised if the
patient receives these treatments. Where practical, the pump should be turned off before
application of electric currents to the patient’s body. Confirmation that the pump programming has
not changed must be carried out as soon as possible after the procedure.
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Radiation.
Do not use radiation therapy in the area of the pump. The effects of ionizing radiation
on the Prometra II Pump have not been established, and these therapies may have effects on pump
operation that are not immediately apparent.
Potential Adverse Events
The use of implanted pumps provides an important means of intrathecally delivering Infumorph.
However, the potential exists for serious complications including the following:
Possible Risks Associated with Programmable Implantable Pump:
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Adverse reaction to pump materials
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Battery depletion
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Bleeding
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Body rejection phenomena
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Defective pump (e.g. propellant chamber leakage, pump rupture)
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Inability to locate septum
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Inability to program pump due to programmer failure or loss of telemetry
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Inflammation, necrosis, or scarring of skin over implant area
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Programming errors, resulting in over or under dosing
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Pump flipping or twisting
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Pump implanted too deep, resulting in difficulty accessing or inability to access port
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Pump migration
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Pump pocket pain/soreness
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Pump pocket seroma/hematoma, with or without infection
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Pump rotation
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Pump site skin erosion
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Pump stoppage
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Refill errors, including injection into pump pocket, injection into wrong port, incorrect volume,
incorrect concentration, difficulty accessing pump port
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Septum dislodgement
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Septum leakage
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Slow, erratic or fast flow
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Software error
