MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
Confusion/ Disorientation (2553)
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Event Date 01/05/2022 |
Event Type
Injury
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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 baclofen (2000 mcg/ml at 1400 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.It was reported that the reporter was called to check the patient¿s pump as the patient had been admitted to the hospital and per the patient¿s daughter her pump was alarming.The patient was also confused and per the nurse, had a uti (urinary tract infection) as well.It was noted that the patient was due to have her pump replaced in (b)(6) due to eri (elective replacement indicator) showing (b)(6) 2022.When the pump was checked, a pump warning came up with pump stopped longer than 48 hours.The pump logs were checked and showed that the pump had been stalling and recovering since (b)(6) 2022.On (b)(6) 2022, the pump stalled and never recovered showing stopped pump longer than 48 hours on (b)(6) 2022.On (b)(6) 2022, the pump was replaced.The catheter did clear.35 ml of baclofen was removed from the old pump and placed in the new pump and the pump dose was started at 750 mcg/day.
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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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Manufacturer Narrative
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H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.H10: interrogation of the pump upon receipt indicated the pump was delivering lioresal 2000mcg/ml at 1,408.1 mcg/day 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 reported that the patient had a sudden loss of therapy.
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Manufacturer Narrative
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H3:destructive analysis identified residue and wearing in the motor.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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