MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Device Ingredient or Reagent Problem (2910)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8709sc, lot#: n274486004, implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (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 multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving dilaudid (1 mg/ml at 0.0588 mg/day) via an implantable pump for non-malignant pain.It was reported that during a recent refill in (b)(6) 2021, the home infusion nurse notified the hcp that they aspirated cloudy fluid from the pump with no obvious explanation.This was followed by a less than expected 8 ml volume discrepancy.Subsequently, the hcp had the home infusion nurse refill the pump with normal saline until surgical revision could be completed to determine the cause of the volume discrepancy and cloudy fluid presence.There were no known factors that may have led or contributed to the issue. the hcp opened the pump pocket and noted a presence of cloudy fluid.They did not feel as though this was infectious in nature.No swabs or cultures were collected.The pump was disconnected from the intrathecal catheter to allow the hcp to dissect out the existing catheter.Once the catheter was dissected out, the hcp was again able to easily aspirate spinal fluid from the intrathecal catheter.The hcp was given a new intrathecal pump, which was attached to the existing intrathecal catheter.At this time, the hcp again aspirated cerebrospinal fluid from the catheter port site.When the hcp attempted to push the fluid back through the port, they noticed leaking around the bell/hub where the catheter attaches to the pump.Subsequently, the hcp opted to replace the proximal pump segment of the existing catheter.The hcp was given an 8596sc intrathecal catheter pump segment revision kit.They trimmed approximately 1 cm from the spinal segment and attached the new proximal pump segment.The new pump was then attached to the new proximal pump segment, at which time the hcp again aspirated cerebral spinal fluid through the catheter access port.The hcp repeated the process of pushing the fluid back through the catheter port site, and there was no further leaking noted at the connection between the spinal segment and proximal pump segment or at the catheter bell/hub where the catheter attaches to the pump.The pump was then placed back in the pocket and the incision was closed.The issue was resolved at the time of report.The patient's weight and medical history were asked but unknown.The patient's status at the time of report was alive - no injury.
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Manufacturer Narrative
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H3: the catheter was returned and analysis upon inspection of the sutureless connector (sc) identified coring in the cup of the connector.The pump was returned and analysis found the pump exceeded the dispense accuracy specification by dispensing more fluid than the programmed rate during testing in the lab.Please note that dispense testing in the lab is not designed to fully replicate the clinical experience.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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