MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Kinked (1339); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Connection Problem (2900); Material Integrity Problem (2978)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099)
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Event Date 01/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 8780, serial (b)(4), implanted: (b)(6) 2015, product type: catheter.Product id: 8785, lot# n718918, implanted: (b)(6) 2018, product type: catheter.Product id: 8784, serial (b)(4), implanted: (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 from a healthcare professional via a company representative regarding a patient receiving morphine (2 mg/ml at 0.35 mg/day) via an implanted pump.The indication for pump use was post lumbar laminectomy syndrome and non-malignant pain.On (b)(6) 2018 the patient was in the operating room for a pocket revision because the pump was confirmed to be flipped.When they opened the patient up, they noticed that the pump segment of the catheter had been completely twisted and kinked.The reporter was guessing that the pump had flipped multiple times.The spinal portion was twisted as well, but they were able to get csf (cerebrospinal fluid) backflow so they didn¿t feel the catheter was twisted to the point of occlusion.The physician was having difficulty getting the catheter connector onto the existing catheter which previously had been twisted.The patient was supine, so they could not replace the entire section of the catheter, so they were trying to remove as much as they could; however, the catheter connector was not sliding onto the catheter enough.They were planning on aspirating after they got the catheter connected to check for patency.Per the reporter, the catheter was ¿very kinked¿ all the way to the spine segment due to the pump flipping, so the pump segment was explanted/replaced.They were able to get csf before they connected the new pump segment, but then could not get csf from the cap (catheter access port) after connecting the catheter to the pump.Prior to the procedure, they had refilled the pump on an unknown date and discovered when aspirating that the pump had not been delivering medication which was likely due to the catheter kinking.The expected residual volume at that refill visit was 18.5 ml and they removed 39.5 ml from the pump.Additional information received on 18-jan-2018 reported that the date of the refill visit where the volume discrepancy was discovered was (b)(6) 2018.The symptoms the patient experienced related to the event was the patient reported that the therapy was not helping with their pain.Per the reporter the cause of the difficulty with the catheter connector during the procedure on (b)(6) 2018 was determined and the cause was the catheter being twisted and kinked so much that it was difficult to reconnect it to the catheter connector.We were unable to insert a new catheter in the spine during that procedure.The cause for the inability to aspirate from the cap (catheter access port) after the catheter was connected to the pump during the procedure on (b)(6) 2018 was not determined.The actions/interventions were taken or planned to resolve the inability to aspirate from the cap after the catheter was connected to the pump were they would monitor the patient to see if she is able to receive therapy.If not, she will have a consult for a re vision.No further complication were reported.
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Manufacturer Narrative
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Analysis of the catheter (sn; (b)(4)) found the catheter body had significant twisting that may have affected infusion and the catheter body had damage to the transition tube.The catheter was returned in segments and no leaks were identified.Initial patency testing found the catheter to be occluded.The occlusion broke loose during the decontamination process and passed subsequent patency testing.If information is provided in the future, a supplemental report will be issued.
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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 manufacturer's representative (rep).It was reported that the catheter was to be returned to the manufacturer for analysis.
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Search Alerts/Recalls
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