MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Positioning Problem (3009); Insufficient Information (3190)
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Patient Problem
Purulent Discharge (1812)
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Event Date 11/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8781, lot#: hg4thhb14, implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter.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 foreign healthcare provider via a distributor regarding a patient receiving gabalon (concentration: unknown, dose rate: 180 mcg/day) via an implantable pump.The indication for use was head injury.It was reported that around (b)(6) 2021, at the time of pump refill, suppuration around the pump was verified.The date (b)(6) 2021 is considered an approximate date of event (specific month and year known only).An operation was considered if there was no improvement after follow-up.On (b)(6) 2022, they changed the position of the pump and implanted again with a new pump and catheter.They had removed the old pump and catheter.As per an attending physician¿s assessment, it was noted that it was not clear but judging from the position of the suppuration, it was possible that the shape of the pump did not match.A pump operability test and rotor test were not performed.Regarding causality, the event was not related to drug, catheter, programming, or surgical procedure.Regarding causality it was unknown if related to the pump.As of (b)(6) 2022, the outcome of the event was noted as remission.
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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.It was stated the cause of the issue was unknown.The explanted pump and catheter would not be returned as they were discarded by the customer.
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Event Description
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Additional information was received from a foreign healthcare provider via a distributor.Regarding the report of the possibility that the shape of the pump did not match, it was clarified that the suppuration was due to the corner of the pump.
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Manufacturer Narrative
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H6 update: the previously applied device code a26 is no longer applicable.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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Continuation of d10: product id 8781 lot# hg4thhb14 serial# implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type catheter 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 distributor on 2022-feb-28.It was reported that the event severity classification was listed as "hospitalization or prolongation of hospitalization".However, the outcome as of (b)(6) 2022 was listed as "recovering".After the procedure on that date, no additional problems had been detected so far.No patient death was reported.It was noted that since the purulent part hit the corner of the pump, the possibility of a pump was considered.
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Search Alerts/Recalls
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