MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Infusion or Flow Problem (2964); Material Integrity Problem (2978)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016 explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-apr-2018, 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 via a company representative regarding a patient receiving lioresal 2,000 mcg/ml at 96.2 mcg/day via an implantable pump.It was reported that the patient as not receiving adequate therapy from the pump.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue.The healthcare provider had done a catheter dye study on (b)(6) 2022 and in his note stated unable to successful aspirate the catheter- will refer to the surgeon for a pump change and possible catheter revision.During the procedure on (b)(6) 2022, the surgeon was able to successfully aspirate the catheter from the catheter access port and when the catheter was disconnected from the pump there was free flowing fluid.The physician did replace the pump segment of the catheter due to it being damaged slightly after being removed the from old existing pump.He dissected down to the collette and found an anchor in the pump pocket.After putting slight tension on it the entire catheter came out freely.Confirmed under x-ray that there was no remaining catheter left in the patient; he did replace the catheter entirely along with the pump.The patient left the or with a fully new and working system.The dosage was adjusted accordingly per the managing physician.The issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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