MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Fall (1848)
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Event Date 02/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Other applicable components are: product id: 8782, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter.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 via manufacturer representative from a healthcare professional (hcp) and a patient who was receiving fentanyl (50 mcg/day, 50 mcg/ml) via intrathecal drug delivery pump for spinal pain.It was reported that the patient had a fall.There had been a progressive csf (cerebrospinal fluid) leak from the spinal incision, which may have been caused by the fall.The spinal incision was opened and explored due to the ongoing csf leak.The hcp stated that there was a risk of infection so they decided to explant the spinal segment and close the catheter track.Pocket exploration and a pocket revision were performed.The pump and pump segment were left in patient and the hcp would return at a future date to re-implant the spinal segment of the catheter.The explanted catheter would not be returned as the customer refused.The pump was turned to minimum rate.The issue was not resolved and the patient status was "alive - no injury" at the time of this report.No further complications were reported.
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Search Alerts/Recalls
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