MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problems
Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Test Result (2695)
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Event Date 08/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 manufacturing representative (rep) regarding a patient receiving 2000 mcg/ml of compounded baclofen at 1207.9 mcg/day via an implantable pump.It was reported the patient was experiencing withdrawal symptoms on (b)(6) 2020 and was admitted to the hospital.There were no known external factors at the time of the report ((b)(6) 2020) that may have led or contributed to the reported withdrawal symptoms.A dye study was performed and the catheter was found to be clear.The pump was interrogated and nothing was found to help identify the reasons for the patient's symptoms.It was believed the pump was not providing adequate dosage.The physicians decided they would be replacing the entire system because the patient could not tolerate oral baclofen.The issue was unresolved and pump and catheter remained implanted at the time of the report ((b)(6) 2020).It was noted the patient was currently admitted to the hospital due to their withdrawal symptoms.The patient's medical history included cerebral palsy.
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Manufacturer Narrative
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The pump was returned for analysis and analysis of the pump found no anomaly.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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Manufacturer Narrative
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Continuation of d11: product id: 8780; lot# serial#: (b)(6); implanted: on (b)(6) 2017; 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.
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Event Description
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Additional information received from a healthcare provider and manufacture representative reported the patient had increased spasticity, increased cpk, and concerned of rhabdomyolysis.The reservoir volume was within appropriate range and normal.There were no response to increased itb dose.The patient was given iv fluids and oral baclofen.It was noted the issue was resolved, however, the dose was markedly reduced and oral baclofen mitigated.The device was planned to be replaced on (b)(6) 2020 and returned to manufacture.
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