MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Disconnection (1171)
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Patient Problem
Seroma (2069)
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Event Date 03/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of concomitant medical products: product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2023 and product type: catheter.Suspect medical device information references the main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 25-jan-2025 and udi#: (b)(4).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 the healthcare provider (hcp) via the company representative (rep) regarding patient receiving bupivacaine (unknown dosage/2000 mcg) via implantable pump.It was reported that the patients pump pocket appeared fluid filled per doctor.Upon expected pump replacement, it was found that the catheter pump connector was disconnected in the pocket.The healthcare provider replaced the pump segment with 8596sc and kept the patient for observation/drug titration.The environmental/external/patient factors were not available.The patient weight was asked but unknown.The patient medical history was cerebral palsy.The patient status was alive and no injury.
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Event Description
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Additional information received from the company representative reported that the patient was receiving lioresal (2,000 mcg/ml at 659.9 mcg/day).
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Manufacturer Narrative
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Initial mdr # had erroneously reported the catheter issue on an 8596sc (sn (b)(6), however upon further review it was determined that the issue occurred on the 8731 catheter (sn (b)(6).This report is being sent to confirm this.The pump and catheter were returned for analysis but analysis has not yet been completed; a follow up report will be sent once the results are made available.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 the device passed all testing in the laboratory and no anomalies were identified.The catheter was returned and analysis identified that the suture ring on the catheter connector was broken.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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