MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Kinked (1339); Aspiration Issue (2883); Material Integrity Problem (2978)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 01/25/2017 |
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) 2017, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (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 clinical study regarding a patient receiving unknown drug via an implanted pump.The indication for use was non-malignant pain.It was reported the patient had a lack of therapy due to the catheter being in multiple knots in the abdomen on (b)(6) 2017.The catheter was explanted and replaced.The event status was unknown.The patient's weight was (b)(6).
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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 healthcare provider via a clinical study reported a large residual, volume, unable to find catheter tip on image.The device diagnosis was catheter kink.A catheter access port (cap) contrast study was performed on, (b)(6)2016, and no dye was pushed through.It was indicated the event was unlikely related to the device or therapy and unlikely related to the implant procedure.The catheter was explanted/replaced on (b)(6)2017 and returned to the manufacture.The issue resolved without sequelae on (b)(6)2017.The cause of the knots was not determined.
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Search Alerts/Recalls
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