MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964)
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Patient Problems
Muscle Weakness (1967); Pain (1994)
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Event Date 07/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 21-feb-2022, 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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Event Description
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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving hydromorphone (18 mg/ml at 5.006 mg/day), bupivacaine (32 mg/ml at 8.89 mg/day), and clonidine (300 mcg/ml at 83.4 mcg/day) via an implanted pump.The indication for pump use was malignant pain spine/back.It was reported that the patient had had a 2 week history of increased pain.There were no volume discrepancies at refills, no alarm logs, and no falls or trauma.Today, they attempted a cap (catheter access port) dye study and were unable to aspirate.The hcp was concerned that there was a catheter issue.Additional information was received on 21-jul-2022 from the hcp via the company representative who reported that they programmed the pump to minimum rate.Then later in the evening, the patient was complaining of increased symptoms similar to withdrawal.The hcp saw the patient again and attempted cap aspiration and was unsuccessful.It was decided that they would inject 0.5 ml of dye thru the cap and in doing so, the patient became acutely weak like he had received a bolus.
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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 cause of the inability to aspirate the catheter was not determined.With regards to the actions/interventions that were or would be taken to resolve the issue, it was noted that the patient was put in the hospital overnight on (b)(6) 2022 to be able to monitor his vitals and to monitor him for signs of overdose.The patient was then released from the hospital on (b)(6) 2022.All the feeling in his legs came back and he was doing fine.The devices remained implanted and were working.Nothing was being explanted.
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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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