MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Insufficient Flow or Under Infusion (2182); 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 Date 04/13/2022 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider via a company representative regarding a patient receiving dilaudid 15mg/ml at 5.5mg/day via an implantable pump.It was reported that the patient was in for a refill on 06-apr and the reservoir volume was supposed to be 5ml and actual was 15 ml.The patient returned today for a roller and dye study and the company representative was requested for assistance programming.The patient is not reporting any signs symptoms of withdrawal.The environmental, external or patient factors that may have led or contributed to the issue was the patient had their gallbladder removed in february and had a large quick weight loss due to this.The diagnostics and troubleshooting performed was the roller study done today was normal.The dye study was attempted but they could not aspirate the catheter.The actions and interventions taken to resolve the issue was surgery was scheduled for a catheter revision on (b)(6) 2022.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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Manufacturer Narrative
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Continuation of concomitant medical products: product id 8780 , serial# (b)(4), implanted: (b)(6) 2015, product type : catheter ,ubd: 07-may-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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 a healthcare provider (hcp) via a company representative who reported that the explanted portion of the catheter wasn¿t faulty.The hcp just wanted a shorter piece in the pocket.
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Event Description
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Additional information received reported that the physician opened up the pocket to externalize the pump.The physician noticed some loops scarred into the back of the pocket and released some tissue with the bovie.Once the loops were released the entire original pump section of the catheter was straightened out and he was able to aspirate the catheter.The physician then checked the volume of the pump and it was within 1 cc of expected volume.The physician decided to replace the pump section of the catheter with a shorter segment to reduce the opportunity of ¿kinking¿.The original catheter was working and had no obvious issues.The pump segment was replaced.Per the reporter in short everything was working.The physician decided to shorten and replace the pump segment of the catheter.
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Manufacturer Narrative
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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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