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Model Number 8627L18 |
Device Problems
Unexpected Therapeutic Results (1631); Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Pain (1994); Weight Changes (2607)
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Event Date 06/03/2003 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: non-healthcare professional (consumer).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient who had been receiving an unknown dose and concentration of dilaudid via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported the patient¿s pump did not work since implant, (b)(6)2003.The patient reported they had not used their pump since 2004 or 2005 and it was turned off because it did not work for the patient.It was indicated this happened in 2004 or 2005.The patient reported they gained 86 pounds from implant to the time the pump was turned off.The patient stated she lost 46 pounds after the pump was turned off.No interventions were mentioned.At the time of the report the patient was inquiring about compatibility guidelines for a magnetic resonance imaging procedure (mri).It was reported the mri procedure was not due to a problem with their pump or therapy (it was unrelated).The patient reported they were experiencing symptoms; however, the symptoms were not related to their device or therapy.It was recommended the patient¿s healthcare provider call for mri information.Physician listings were provided to the patient.No further complications were reported or anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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