MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number NEU_UNKNOWN_PUMP |
Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/15/2023 |
Event Type
malfunction
|
Event Description
|
Information was received from a foreign healthcare provider (hcp) via a distributor regarding a patient receiving gabalon of an unknown concentration at an unknown dose rate via an implantable pump.The patient¿s past medical history was unknown.It was reported that there were cases where pump interrogation was not possible.Confirmation by fluoroscopy was suggested.It was confirmed that the pump was most likely inverted.The physician commented there was a high probability of pump inversion / reversal.The onset of the suspected pump inversion was mid-july.The date (b)(6) 2023 is considered an approximate date of event (specific month and year known only).The outcome of the event was indicated as not recovered.It was noted that if interrogation is not possible, it will be corrected with surgery.It was further noted that in case of reparative surgery, a set of supplies should be prepared in case of the indura catheter.Regarding the causal relationship of the suspected pump inversion, the issue was indicated as having been unrelated to drug, pump, catheter, and programming.The causal relationship to procedure was however unknown.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 8711.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.
|
|
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
|
Additional information was received from a foreign healthcare provider via a company representative.The model number, seri al number, and implant date of the pump associated with the event was unknown.Itwas unknown if surgery was performed to resolve the suspected pump inversion and inability to communicate.Actions taken/planned to resolve the issue were unknown.Regarding the pump likely inverted, there were no known circumstances/factors that might have led to the event.It was unknown if the suspected pump inversion and inability to communicate/interrogate the pump had been resolved.The devices/pump was still in use and therefore would not be returned to the manufacturer.
|
|
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
|
|
|