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Model Number 8627L18 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Fall (1848); Paralysis (1997); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Ambulation Difficulties (2544); Cognitive Changes (2551)
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Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 (con) regarding a patient receiving morphine of an unknown concentration and unknown dose and dilaudid of an unknown concentration and unknown dose via an implantable infusion pump for malignant pain and spine/back pain.It was reported by the patient that she received a manufacturer's id card but has had her pump removed.The patient stated that about 3 years after her implant date of (b)(6) 2002 she woke up paralyzed from the waist down.Patient stated she was feeling sick with vomiting and diarrhea and when she woke the next morning and tried to get out of bed she fell flat on her face.Patient stated that as an intervention she had a total system explant in (b)(6) 2007-2008 after which the doctor told the family and boyfriend that he "ripped the pump system right out of the patient".Patient stated that after the pump was pulled out the patient went through withdrawals and was a maniac and they were treating her like a drug addict.Patient was in a wheel chair for almost a year.Patient states she then went to the mayo clinic and they diagnosed her with advanced multiple sclerosis and told her she would probably never walk again.Patient stated she was able to walk now.The situation was resolved and patient was able to walk and all sickness and withdrawal issues had been resolved.The patient noted she was scheduled to have a stimulation device implanted on (b)(6) 2017.
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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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