MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Obstruction of Flow (2423); Improper Flow or Infusion (2954); Insufficient Information (3190)
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Patient Problems
Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8709 , lot# j0056653r, implanted: (b)(6) 2001, product type :catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 20-nov-2002, udi#: (b)(4).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 healthcare provider (hcp) regarding a patient receiving intrathecal sufenta (concentration and dose unknown) via an implanted pump for spinal pain, non-malignant pain, and failed back surgery syndrome.It was reported every time they do a refill, the patient had overdose type symptoms including lightheadedness and has had to go to the emergency department (ed) after multiple refills because of this.It was noted the patient was concerned a "valve" in the pump may be allowing her to get overdosed after refill and was concerned that the pump would fail completely and overdose her.It was further reported the patient had been having volume discrepancies for some time, but did not specify for how long.He believed the catheter was occluded, however al so stated that the patient wanted the pump out so they had been weaning her down prior to removing the pump.
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Search Alerts/Recalls
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