MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013); Post Operative Wound Infection (2446); Tissue Breakdown (2681)
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Event Date 10/01/2021 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (manufacturer representative, distributor, healthcare provider, foreign) regarding a patient who was receiving morphine of an unknown concentration at an unknown dose rate via an implantable pump.It was reported that the patient¿s morphine pump had been taken out at the end of (b)(6) 2021 due to inflammation and pus of the wound after implantation.It will not be considered to re-implant the product later.The date (b)(6) 2021 is considered an approximate date of event (specific year known only).The date (b)(6) 2021 is considered an approximate date of pump explant (specific month and year known only).
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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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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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The patient's product was explanted.
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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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Additional information was received from a foreign healthcare provider via a clinical study.The onset / date of the event was unknown.The patient had an infection.It was noted that the patient stated that the wound at the implantation site after the operation became purulent, which became more and more serious afterwards resulting in exposure of the device.Factors that may have caused or contributed to event were unknown.Regarding if the issue resolved, it was further indicated that the patient had been implanted with product and there were no other discomforts.The patient¿s weight at the time of the event was unknown or would not be provided.The explanted device would not be returned to the manufacturer as the hospital had treated the device as medical waste.
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Manufacturer Narrative
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B5 correction: it was previously reported that additional information was received from a foreign healthcare provider via a clinical study in error.The b5 narrative / event description of the previous report (follow-up # 1) has been corrected in this report.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 was received from a foreign healthcare provider and distributor via a company representative.The onset / date of the event was unknown.The patient had an infection.It was noted that the patient stated that the wound at the implantation site after the operation became purulent, which became more and more serious afterwards resulting in exposure of the device.Factors that may have caused or contributed to event were unknown.Regarding if the issue resolved, it was further indicated that the patient had been implanted with product and there were no other discomforts.The patient¿s weight at the time of the event was unknown or would not be provided.The explanted device would not be returned to the manufacturer as the hospital had treated the device as medical waste.
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Search Alerts/Recalls
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