MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
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Patient Problems
Granuloma (1876); Insufficient Information (4580)
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Event Date 02/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, lot#: unknown, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: unknown.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, healthcare provider, foreign) regarding a patient who w as receiving morphine (10 mg/ml at 1.529 mg/day) via an implantable pump.It was reported that the patient's medical history included chronic pain.A possible blocked catheter was suspected.During a pump refill, the physician withdrew 34 ml of morphine verses th e estimated (expected) 6.2 ml as per the clinician programmer.The patient's pain relief was not sufficient.Factors that may have led or contributed to the issue was noted as being not applicable.No troubleshooting was yet performed.The physician planned to perform a contrast study in theater, and if they catheter is blocked they will replace the spinal catheter.Surgery was scheduled for (b)(6) 2022.The issue was not resolved as of (b)(6) 2022.The patient's age and weight at the time of the event were unknown or would not be made available.
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Manufacturer Narrative
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Continuation of d10: product id: 8780, lot# 0217572879, implanted: (b)(6) 2019, explanted:(b)(6) 2022, product type: catheter.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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Event Description
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Additional information was received from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on 2022-mar-25.It was reported that the contrast study was performed as planned in the theatre under fluoroscopy on (b)(6) 2022.No csf could be aspirated during the procedure, only 0.2 ml of the catheter volume could be aspirated.The hcp opted not to inject any contrast dye and replaced the spinal catheter that same day.A granuloma was observed at the tip of the removed catheter, blocking any flow.The patient's same pump remained implanted and the old catheter was discarded.The issue was considered resolved.
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