MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 8731,serial# (b)(4), implanted: (b)(6)2004, product type :catheter; product id 8596sc , serial#(b)(4), implanted: (b)(6) 2011, 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 company representative (rep) regarding a patient receiving bupivacaine (15 mg/ml at 4.124 mg/day) and hydromorphone (30 mg/ml at 8.249 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the company representative (rep) wanted to know the volume of the extension tubing.The rep stated that they expected 38.5ml and aspirated 35ml from the reservoir.The rep stated that they will monitor for volume discrepancies and patient symptoms and will look into catheter diagnostic testing if need be.
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Manufacturer Narrative
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Continuation of d10: product id 8731 lot# serial# (b)(6) implanted: (b)(6) 2004 explanted: product type catheter product id 85 96sc lot# serial# (b)(6) implanted: (b)(6) 2011 explanted: 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 received from the company representative stated that the patient weight at time of the event was unknown.The cause of the volume discrepancy was also unknown, no actions/interventions were taken or were planned to resolve the issue.The provider will monitor volumes at next refill.
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Manufacturer Narrative
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Continuation of d10: product id 8731 lot# serial# b011422n21 implanted: 2004-07-31 explanted: product type catheter product id 85 96sc lot# serial# n228260002 implanted: 2011-06-06 explanted: 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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Information was received from a company representative (rep) regarding a patient receiving bupivacaine (15 mg/ml at 4.124 mg/day) and hydromorphone (30 mg/ml at 8.249 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the company representative (rep) stated that they brought the patient to check on the volume in the pump.They got 2-3ml less than expected.They increased the pump dose by 5%.The physician said the patient reported that their pain was not completely under control, but the patient was elderly and a poor historian.The rep asked about dye study and that they will continue to monitor the patient and check volume at the next refill and will discuss a dye study with the physician.
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Search Alerts/Recalls
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