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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Tingling (2171); Numbness (2415); Paresthesia (4421)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781; serial# (b)(4); implanted: (b)(6) 2017; product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-mar-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study on 2020-oct-20 regarding a patient receiving fentanyl (2000mcg at 1709.43659mcg/day), bupivacaine (20mg at 17.09437mg/day), and morphine (5.4mg at 4.61548mg/day) via an implanted infusion pump.It was reported that on (b)(6) 2020, the patient reported a numbness/tingling sensation from the flank down to the leg.The symptoms started on one side, and were now bilateral.On (b)(6) 2020, a catheter dye study failed with dynamic kinking.No action was taken at the time of report, and the event was ongoing.The etiology indicated the event was related to the device/therapy, and was not related to the implant procedure.No further complications were reported, or anticipated.

Manufacturer Narrative

Concomitant medical products: product id 8781 serial# (b)(6) implanted: (b)(6) 2017 explanted: (b)(6) 2020 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.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 received from an hcp via a manufacturer representative indicated that the patient reported increased pain and a dye study was normal, but the catheter appeared to have a kink with certain positions.The myelogram indicated that no leaks were seen and the system was intact and functional, but the catheter system required surgical revision.The catheter was replaced and in surgery, it was noted that the catheter around the collet was causing a kink.Fluid was unable to move through the catheter.The collet was reportedly scarred into a big ball of tissue and when the tissue was dissected out and the collet was removed, the catheter was flowing freely.The issue was considered resolved at the time of report, and there were no environmental, external, or patient factors that may have led or contributed to the issue.The patient's medical chart indicated that the increased pain was in the lower back.The patient was also having right shoulder pain which had increased lately.The patient's pain was described as aching, burning, and crushing and the patient was unable to sleep because of pain.The patient also admitted pain at the pocket site was an ongoing problem.The patient denied new progressive neurological symptoms in the lower extremities.The patient had a transforaminal l umbar epidural steroid injection at l5-s1 ordered as well as they had 90% relief with their past tlesi on (b)(6) 2020.The patient took percocet 5mg once per day and would continue.A lumbar mri was reviewed with the patient from (b)(6) 2020 which indicated moderate right/mild to moderate left foraminal stenosis with an l5 nerve root impingement on the right/encroachment on the left.Mild stenosis at l2-l3 and l1-l2 was noted as well as mild facet degeneration.Tlesi and possible surgical consult were discussed but the patient wanted to avoid surgery and see if fixing the catheter would help with their pain.It was noted that the numbness into the patient's right thighs had slightly improved.

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 received from a healthcare professional (hcp) via a clinical study reported the outcome of the event resolved without sequelae on (b)(6) 2020.It was noted the catheter was explanted/replaced on (b)(6) 2020.No further complications were re ported/anticipated.

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 via a clinical study on 2020-oct-23.The device diagnosis was catheter kink and the clinical diagnosis was numbness / tingling sensation.Additional information was received from a healthcare provider via a clinical study on 2020-oct-24.The pump was administering fentanyl at a dose rate of 1709.43659 mcg/day, bupivacaine at a dose rate of 17.09437 mg/day, and morphine at a dose rate of 5.12831 mg/day.

Manufacturer Narrative

H3: the catheter was returned, and analysis observed a kink in the catheter body.H6: all previously reported method, result, and conclusion codes no longer apply to this event.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
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10717474
• MDR Text Key: 212470584
• Report Number: 3004209178-2020-18450
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 154