MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Malaise (2359); Weight Changes (2607); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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.It was reported the pump was supposed to be replaced in june this year, but the patient went into the hospital for overdose (od) symptoms and was there for a week, and they realized the catheter was broken.The patient lost 20 pounds that week due to being so sick.Currently, it was noted because of catheter being broken and symptoms reported, the patient had lost 40 pounds now.
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Manufacturer Narrative
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Concomitant products: product id: neu_unknown_cath, serial#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd:unknown , udi#:unknown.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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