MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problems
Migration or Expulsion of Device (1395); Positioning Problem (3009)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 07/18/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: neu_unknown_cath lot# unknown serial# implanted:(b)(6) 2022.Explanted: (b)(6) 2023.Product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown, udi#: unknown 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, foreign, distributor) regarding a patient who was receiving baclofen of an unknown concentration at an unknown dose rate via an implantable pump.The patient's medical history included spasm.It was reported that poor postoperative curative effect occurred.There was almost no effect after implantation, and the patient's pain was hardly relieved.It was further reported that the patient indicated there was no effect after the implantation on (b)(6) 2022 and then decided to explant the product.During the explant process, the physician found that the catheter was not inserted into the spinal cavity, which resulted in no effect.Factors that may have led or contributed to the issue was unable to be provided.The pump/complete device was replaced on (b)(6) 2023 and the issue was resolved.The patient was without 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
|
Additional information was received from a foreign healthcare provider via a distributor.The model number, serial/lot number and implant date of the catheter was unknown.It was unknown if the catheter migrated out of the spinal canal or if the event was regarding a placement issue at the time the catheter was implanted.The pump and catheter would not be returned to the manufacturer; the status of the devices was unknown.
|
|
Manufacturer Narrative
|
H6 update: the previously applied device code a1502 has been replaced with a0104 regarding additional information received.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 and distributor via a company representative.It was reported that the catheter had fallen off for the second time.Refer also to mfr report # 2182207-2023-01774 regarding subsequent event / alternate catheter.Regarding the report of the catheter having fallen off, it was clarified that the first time this issue occurred, the physician¿s operated to replace the catheter.
|
|
Search Alerts/Recalls
|
|
|