MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8637-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient and healthcare provider (hcp) regarding an implanted infusion pump system for spinal pain.At the time of this report, the pump was used to deliver fentanyl 50mcg/ml.Dose information was not reported.It was reported that the pump was replaced on 2023-09-24 for normal battery depletion.Upon entering the capsule surrounding the pump, there was a chalky white fluid encountered.This did not appear to be purulent and there was no associated erythema or breakdown.The surgeon suspected that this very well may have been essentially a liquefication of the prior pouch that the device had been place in, as it was over seven years old.This was sent for culture, just to be certain, but ultimately the capsule was fully dissected and the device was carefully rotated out.The attachment "from the nausea" was carefully removed and the pump was passed to the back table.The fentanyl from the prior pump was transferred into the new pump after removing the saline from the new pump.This was accomplished without issue.The pocket was copiously irrigated with bacitracin saline as well as betadine solution.Again, t here did appear to be essentially breakdown of likely an old an old pouch that had been removed and "prior time is my best guess", but there was no evidence of inflammatory changes, purulent material breakdown, or anything else that would hint at infection.The catheter was inspected and did appear to be intact without breaks or disconnects.There was no evidence of breakdown.The tip was attached to the nozzle of the new pump and secured using a 2-0 silk suture.The surgeon was able to easily withdraw approximately 1.5ml of cerebrospinal fluid (csf) to clear the catheter and this was colorless and, again, the surgeon felt that there was good patency of the spinal catheter.The device was carefully placed back into the pocket and care was taken to ensure that there was no kinking of the catheter.Any excess catheter was coiled behind the device.2-0 vicryl sutures were then used to close the device capsule followed by 3-0 vicryl sutures in layers followed by monocryl and dermabond for the skin.Overall, the procedure was tolerated well and there were no apparent complications.The patient's managing doctor was aware and the patient would follow up with them in two to three days as an outpatient.The surgeon did discuss with the managing doctor supplementing with oral pain medications until the patient's follow-up and the doctor agreed that this was reasonable if the patient's needed it.The patient was awake, alert, and conversant, moving all extremities, with a stable neurologic exam on tolerable pain post-operatively.It was noted that there was no pump issues, other than the normal batter depletion.The reporter was unsure of the patient's weight at the time of the event.
Additional Manufacturer Narrative
Continuation of d10: product id: neu_pouch_acc.Product type: accessory section d information references the main component of the system.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.
Additional Manufacturer Narrative
G2.All report sources have been updated/corrected.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.

• Brand Name: SYNCHROMED II
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17840833
• Report Number: 3004209178-2023-16707
• Device Sequence Number: 4401323
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/16/2023
• Date Device Manufactured: 10/30/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female