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
Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)
|
Event Date 01/01/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2023.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4) ubd: 14-oct-2018, 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 a healthcare provider regarding a patient who was receiving unknown drug via an implantable pump for unknown indications for use.It was reported that the patient had an incisional dehiscence in the left flank region of the intrathecal pump with evidence of incisional infection.Intraoperative fluoroscopy was performed to identify the lumbar 3-4 level, where it was known that the spinal catheter entered the intrathecal space.The lumbar incision centered over that location.Subcutaneous dissection proceeded to identify the spinal catheter, the anchor for which was also dissected free from subcutaneous scar.The intrathecal catheter was removed and 0 silk purse string suture was used to repair the dural cerebrospinal fluid fistula without need for laminectomy.Hemostasis was obtained with bipolar electrocautery.The left flank was then accessed and the entire pump system was removed including the pump segment catheter and spinal catheter.The system was sent for disposal according to their protocol.The left flank/buttock region was irrigated with copious vancomycin irrigation and were cultured prior to the irrigation along with the cerebral spinal fluid from the spinal catheter.The incisions were then closed.The patient's medical history included diabetes, chronic low back pain and bilateral sciatica.
|
|
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 healthcare provider (hcp) reporting the event date was january 2023.No further information was provided.
|
|
Manufacturer Narrative
|
H3: analysis of the returned pump passed all testing in the laboratory and no anomalies were identified.Analysis of the 8780 catheter identified a tear in the inside sealing surface of the sutureless connector (sc), near the guide ring which did not affect the fu nctionality of the catheter.Interrogation of the pump upon receipt indicated the pump was used to deliver hydromorphone 180.0 mcg/ml at 20.02 mcg/day.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
|
|
|