MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2022 |
Event Type
malfunction
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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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Information was received from a healthcare provider (hcp) regarding a patient who was receiving baclofen at an unknown concentration and dose via an implantable pump for intractable spasticity; head/brain injury.It was reported that the hcp was expecting 3.5 ml and only got 1ml.It was reported that during their previous refills the volume they got back was closer to the expected amount or extra, not less.The calculated discrepancy was about 15% the specification was reviewed at +/- 14.5% and the potential for the mechanism to deliver more than expected.As well as monitoring subsequent refills to see if this might have been anomaly or might be getting worse over time.The patient did not experience any symptoms.
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Event Description
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Additional information received from healthcare provider reported that on (b)(6)2022 the expected reservoir volume (erv) was 3.9 ml and the actual reservoir volume (arv) was 5 ml.The previously programmed volume and previously filled volume was 20 ml.On (b)(6)2022- the erv was 3.9 ml and the arv was 5.5 ml.The previously programmed volume and previously filled volume was 20 ml.On (b)(6)2022the erv was 3.5 ml and the arv was 0.8 ml.The previously programmed volume and previously filled volume was 20 ml.The cause of the volume discrepancies was not determined.No actions were taken to resolve the issue other than thoroughly examining the patient to ensure there was no pocket fill.The event was not resolved.
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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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