MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Pocket Erosion (2013); Scar Tissue (2060)
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Event Date 10/26/2020 |
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 company representative (rep) regarding a patient who was receiving fentanyl (2000 mcg/ml) and bupivacaine (20 mg/ml) via implantable pump.It was reported that the patient's pump was eroding through the skin.It was unknown when the erosion began.At surgery today the exposed pump was removed and a new pump was implanted on the opposite side.There were no external factors to the erosion although the patient has had some weight loss.No growth was noted on cultures as the patient was being followed by a wound specialist.The issue was resolved and the patient was without injury at the time of the report.The pump will be sent back for analysis.
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Event Description
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Additional information received from a healthcare professional (hcp) via a clinical study reported on 2020-oct-26.Examination of the pump area revealed the areas to be rubbing and caused a bruise.It was noted the pump was easily palpable on the edge.On (b)(6) 2020.The pump site had a 2 inch black eschar at the lateral aspect of the pump.The patient was referred to wound clinic for evaluation and treatment.On (b)(6) 2021 a call from the wound clinic indicated the pump was exposed.On (b)(6) 2021 the pump was explanted from the left wound side and a new pump was place in the right side.Cultures were collected.The outcome of the event resolved without sequelae on (b)(6) 2021.The clinical diagnosis was skin erosion at the pump pocket site.The patient was receiving fentanyl 2000 mcg for a total dose of 1333.47802 mcg/day and bupivacaine 20 mg for a total dose of 13.33478 mg/day.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The incisional site/device tract was pump pocket.No further complications were reported/anticipated.
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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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Manufacturer Narrative
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H3: the pump was returned and analysis found no anomaly.H3: the catheter was returned, and analysis found no significant 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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