MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Obstruction of Flow (2423); Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving dilaudid (1 mg/ml, 0.60 mg/day) via implanted infusion pump.It was reported the patient was scheduled for a routine pump replacement on (b)(6) 2022 due to elective replacement indicator (eri) less than 10 months (the physician routinely replaced his pumps at this time to prevent abrupt motor stall).While in preop, the hcp performed a catheter access study and was unable to aspirate cerebral spinal fluid (csf).It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The patient was taken to the operating room for routine pump replacement.The hcp started by opening up the pump pocket and dissecting out the exiting pump and proximal pump segment.Once the pump was removed from the pump pocket, the hcp again attempted to aspirate from the catheter access port, but was again unsuccessful.The old pump and proximal segment were removed and placed on the sterile field.The hcp then proceeded to use preservative free normal saline and a 1 ml syringe to flush the catheter.After multiple flushes, the hcp was able to aspirate from the catheter and csf was seen dripping freely from the catheter.The physician then proceeded to reattach the proximal pump segment and the new pump.A final aspiration was done to confirm patency of the catheter.The issue was resolved at time of report.The rep noted because of the case of the obstruction and length of time the obstruction may have occurred was unknown, the patient's dosing was reduced to prevent symptoms of drug overdose/toxicity.The new daily dosing was reduced to dilaudid (0.40 mg/day) and the concentration was unchanged.The patient's medical history was asked, but unknown.The patient's status at time of report was alive - no injury.No symptoms were reported.
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Manufacturer Narrative
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Concomitant medical products: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2016 product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 12-oct-2018, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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