MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problems
Filling Problem (1233); Infusion or Flow Problem (2964); Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/19/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 8551, product type: accessory.Product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), 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.
|
|
Event Description
|
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving baclofen (4000 mcg/ml at 10323 mcg/ml) via an implantable pump for intractable spasticity.It was reported that eri (elective replacement indicator) was triggered for the pump.No symptoms were reported.The patient was due for a new pain pump due to eri.Prior to surgery today, in the operating room a catheter dye study was performed.The doctor was unable to get any csf (cerebral spinal fluid) back.It was decided that a catheter revision would need to take place as well as the pump replacement.The previous catheter was tied off and remained implanted in the patient but not in use.The other issue was when they opened the pump and the scrub tech was trying to remove the sterile water that ships inside the pump with the black needle, the tech was not getting any water to come out of the pump.The tech shook the pump and could hear that there was fluid inside of it.They asked the tech to switch over to the purple needle and see if fluid would come out with that needle.The purple needle was able to extract water from within the pump.At that time they opened a refill kit to try a different black needle.The second black needle we used worked like normal use.They thought there might be an issue with the black needle that came in the pump kit. the patient's weight and medical history was asked but unknown. the patient was reported alive with no injury.The issue was reported to be resolved at the time of this report.Additional information was received that the cause of the inability to get csf flow was undetermined.
|
|
Manufacturer Narrative
|
H6.All previously reported device codes will be updated/corrected to the following for this event: a14.The previously reported img codes: g04092 and g04105 are no longer applicable to this event.Imf code f26 was updated/corrected to f1205.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
|
|
|