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Model Number 8637-40 |
Device Problems
Insufficient Flow or Under Infusion (2182); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
Injury
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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 multiple sources (healthcare provider, clinical study) regarding a patient who was receiving dilaudid (7.5 mg at 3.86415 mg/day) and bupivacaine (30 mg at 15.4566 mg/day) via an implantable pump for unknown indications for use.It was reported that during a pump refill, it was noted that the pump was air locked and only 35 ml of medication could be injected into the 40 ml pump reservoir.Additionally, a significant reservoir volume discrepancy was noted: expected reservoir volume 11.8 ml and actual reservoir volume was 23 ml.The pump was refilled again and air locked where only 33-35 ml of medication was injected into the 40 ml reservoir.The patient reports stable pain control.The pump was replaced.Examination of explanted pump reveals the pump was indented.Device returned to medtronic.
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Search Alerts/Recalls
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