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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problems Diarrhea (1811); Itching Sensation (1943); Nausea (1970); Pain (1994); Diaphoresis (2452); Ambulation Difficulties (2544); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 25-feb-2015, 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 via a clinical study regarding a patient who was receiving fentanyl (2000 mcg at 1200.52106 mcg/day), bupivacaine (21.6 mg at 12.96563 mg/day), and morphine drug, unknown (7.9 mg at 4.74206 mg/da) via an implantable pump for unknown indications for use.It was reported that on (b)(6) 2020 the patient reported that they woke up with increased bilateral leg pain, nausea, and sweating-exact same way as the last catheter revision.  a catheter access port (cap) contrast study was performed and was normal.  the pump was reprogrammed where the ptm was increased to 100 mcg.  the outcome of the event was noted as ongoing.  the clinical diagnosis was increased pain.  the etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was not related.  the relatedness to the drug (fentanyl) was possibly related and the drug action that caused the event was no change in drug.The event date was (b)(6) 2020.  additional information received from a healthcare professional (hcp) via a clinical study reported on 2020-dec-29 at pump refill the expected residual volume was 1.2mls and the actual/pulled residual volume from pump was 7mls.It was noted the patient had some relief with boluses.A catheter revision was requested as there was a possible dynamic kink.The device diagnosis was pump reservoir volume discrepancy.No further complications were reported/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 an hcp via a clinical study reported on 2021-jan-13 the patient reported there pump was working well and that they will not be proceeding with the plan for now.No further complications were reported/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.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported the pump was programmed to 40ml at refill on (b)(6) 2020.No further complications were reported / anticipated.

Manufacturer Narrative

Continuation of d10: product id 8781 serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2021 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.

Event Description

Additional information was received from a consumer and healthcare provider via a company representative.Past medical history included history of endometriosis, depression, hyperlipidemia, and hypothyroidism.Past surgical history included appendectomy and bilateral pudendal nerve compression.The patient¿s assessment / diagnosis was complex regional pain syndrome of other specified site; pelvic and perineal pain.The pump administered the following medications as of (b)(6) 2021 : fentanyl (concentration: 2000.0 mcg/ml, dose rate: 1.321/0 mcg/day), bupivacaine (concentration: 21.6 mg/ml, dose rate: at 14.267 mg/day), and morphine (concentration: 7.9 mg/ml, dose rate: 5.2178 mg/day).Other concomitant medications included the following: citalopram 40 mg, imitrex 25 mg, percocet (5 mg0325), synthroid 137 mcg), and zyrtec (10 mg).The patient had no known drug allergies.The patient¿s height was 5 foot 8 inches.Their weight was 178 pounds.The patient experienced intermittent pain relief.The date of the event was reported as (b)(6) 2020.It was noted that when it worked it¿s great but when it doesn¿t the patient had withdrawal like symptoms.The patient was seen by the healthcare provider on (b)(6) 2020 reporting increased pain and withdrawal symptoms.A catheter dye stud performed on (b)(6) 2020 was normal.At the time of the procedure, it was noted that approximately 2 ml of clear cerebrospinal fluid (csf) had been aspirated via the catheter access port.No leaks were seen and contrast could be seen exiting the intrathecal catheter tip (tip at t12 level).Dye had dispersed freely without restriction in the intrathecal space.The patient¿s boluses were increased to 100 mcg.The patient later reported at a healthcare provider visit that they were hot and cold, were sweating, were nauseated, had diarrhea, itching in their bilateral legs, and had increased pain.It was noted that this was worse when the patient wakes up in the morning, and mid-day the patient would begin to feel better after she used her boluses.When the patient gave herself a bolus she would get pain relief for one hour.Overall, the patient rated her pain a 6 to 7 on a pain scale of 10.It was noted that the patient was basically in bed all weekend.The patient was prescribed vistaril, and they had taken 50 mcg twice yesterday and she did not get relief of her withdrawal like symptoms.The patient was advised to take two tablets per day, 4 times a day, and see if this would help her symptoms.The patient also had zofran that was prescribed previously.They planned to also prescribe oxycodone 5 mg (one to two tabs every 6 hours as needed).It was further indicated that the catheter may have had some dynamic kinks in it.The catheter w as replaced on (b)(6) 2021.The issue was resolved.The patient was without injury regarding their status as of (b)(6) 2021.The complete catheter was explanted and was in the possession of the company representative.The catheter was to be returned to the manufacturer.

Event Description

Additional information received from a healthcare provider via a clinical study reported the catheter proximal to the anchor had twisted and had several memory bends.The device diagnosis was intermittent kinking.

Manufacturer Narrative

Continuation of d10: product id: 8781, serial# (b)(6), implanted: (b)(6) 2015, explanted: (b)(6) 2021, 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

H3: the catheter was returned, and analysis found a kink in the catheter body and found the anchor was broken.H6: all previously reported method and result 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: 11111805
• MDR Text Key: 226120081
• Report Number: 3004209178-2021-00078
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 81