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Model Number 8627L18 |
Device Problem
Battery Problem (2885)
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Patient Problems
Nausea (1970); Therapeutic Response, Decreased (2271)
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Event Date 12/01/2017 |
Event Type
Injury
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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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Event Description
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Information was received from a consumer regarding a patient receiving intrathecal unknown morphine (concentration and dose unknown) via an implanted pump for non-malignant pain.Physician listings were requested.The reason for the call was to find out the refill date and the patient was redirected back to the healthcare provider (hcp).It was further reported the pump battery failed and she went into withdrawal and rushed to the emergency room.The patient needed to have surgery to have a new pump put in.It was noted the pump failed (b)(6) 2017 and the patient experienced withdrawal (b)(6) 2017.The patient experienced a lot of nausea in (b)(6) 2017.It was also reported on an unknown date, the patient could not feel her hands because she had rheumatoid arthritis and it had formed a calcium cage in her neck which caused her not being able to feel her hands/nerves not working.The patient had surgery on her neck 20 years ago in the 1990¿s no further complications were reported/anticipated or expected.
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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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Event Description
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Additional information was received from a healthcare professional (hcp).There was no therapy issue.The device was at end of life when the patient was referred to the hcp but authorization was pending.The original provider no longer cares for her.The cause of the pump battery failing was determined to be end of life known to patient and insurance company.The battery failure, withdrawal and nausea resolved more than six months ago.The patient¿s weight at the time of the event was noted as morbidly obese.Replacement was (b)(6) 2017.
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Search Alerts/Recalls
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