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)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 02/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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References the main component of the device system the relevant components include: product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, 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 (hcp) via a manufacturer's representative (rep) regarding a patient receiving 16 mg/ml morphine at a dose of 0.99 mg/day via an implantable infusion pump for spinal pain.It was reported that the patient had a lack of therapy.The hcp reported pulling out 38 cc at last refill in (b)(6) 2018.The pump said 3 cc in pump and the hcp pulled out 38.An environmental/external/patient factors that may have led or contributed to the issue was that the patient's pump flipped.A catheter and dye study was performed on (b)(6) 2018.The hcp was unable to aspirate from the access port as well as push dye.As an action/intervention taken to resolve the issue, the patient was sent to the surgeon for catheter replacement.The issue was not resolved at the time of this report.Surgical intervention was planned, after diagnostic catheter and dye study it was suspected that the catheter was kinked.The hcp was to be sending a referral to a surgeon for a revision.The patient's status was "alive - no injury" and no further complications were expected or anticipated.
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Search Alerts/Recalls
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