MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fall (1848); Dysphasia (2195); Numbness (2415); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 08/09/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving fentanyl (3760 mcg/ml at 543 mcg/day) and bupivacaine (30 mg/ml at 4.3 mg/day) via an implanted pump.The patient¿s medical history was type 1 diabetes.The indication for pump use was failed back surgery syndrome and non-malignant pain.It was reported that the patient went to work out one morning and gave himself a ptm (personal therapy manager) bolus prior to his exercising.He then went to a park with his dog and felt like his legs were going numb and he couldn¿t walk.He had to call 911 because he fell outside of his car and could not get up.There were no environmental, external, or patient factors that may have led or contributed to the issue.The patient¿s hcp wanted the pump replaced and the catheter checked due to this episode.The patient was currently on the exact same concentration and dose as he was when the event occurred.The pump was removed and replaced without difficulty.The catheter aspirated well, and 2 ml was drawn back to empty the catheter.The catheter was not replaced.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
|
|
Event Description
|
Additional information received from the company representative (rep) regarding the patient and healthcare provider information.The device was shipped at the beginning of january.The company representative does not have the tracking, but the mpxr report was in the box with it.The information was confirmed with the healthcare provider.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
The pump was returned for analysis.Device was analyzed and analysis showed no 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.
|
|
Event Description
|
Additional information was received from the patient reporting along with not being able to feel their legs, they could barely talk.They knew what they were trying to say, but couldn't.The patient reported when the ambulance picked him up, he was given narcan or something like that to "bring it down".The patient reported they overdosed on what had to be fentanyl in their pump.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|