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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Nausea (1970); Seroma (2069); Tinnitus (2103); Dizziness (2194); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving unknown medication via an implantable pump for unknown indications for use.It was reported that the healthcare provider (hcp) was requesting information regarding csf leaks after pump implant and performing a blood patch to help.The patient was tentatively scheduled for a procedure tomorrow, (b)(6) 2023.Additional information was received reporting that on (b)(6) 2023 the hcp performed a catheter dye study.The pump and catheter were intact and functioning.The patient reported good pain relief.At the catheter dye study, there was fluid in the pocket.The hcp pulled 30 ml's from the pocket.  the patient informed the staff she had fallen since the implant.She also reported a headache.  the cause of the csf leak was not definitive, but suspected the fall may have contributed.The hcp planned to perform a blood patch on (b)(6) 2023.The patient's weight was asked, but would not be made available.

Manufacturer Narrative

Concomitant medical products: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2023, (b)(6) 2023 product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 19-jan-2025, 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.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2023 explanted: 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 healthcare provider (hcp) via a company representative (rep) who reported due to the patient's symptoms (headache, fluid in the pump pocket, etc.), the physician wanted to access the implant sites surgically to assess those areas.The hcp stated he found a pseudomeningocele at the anchor site.The hcp incised it and placed purse strings around the access point of the catheter to the intrathecal space.The hcp stated he did not see fluid coming from the site after that.He stated he did not cut, remove, or alter the catheter during the surgery.The catheter remains in place.No devices were replaced or explanted during the revision.

Manufacturer Narrative

Continuation of d10: product id 8780 serial# (b)(6) implanted: (b)(6) 2023 explanted: 2023-04-25 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 company representative who reported that patient was seen in clinic today by dr.Snell for follow up from a catheter revision surgery done two fridays ago.The physician stated that the patient complained of continued postural headaches and nausea.The patient stated it was better than before the revision, but still present.The physician stated the patient did claim the pump was helping with her chronic pain and didn't want it taken out.The physician increased the pain pump dose and discontinued the antibiotic.The physician would see the patient again in two weeks for follow up on symptoms.

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 professional (hcp) via manufacturer's representative (rep).It was reported that the patient had headaches, pressure, and swelling in pump pocket.The hcp drained a yellow fluid from the pocket once or twice since pump implant and prior to today's date.The patient continued to have symptoms.The physician brought her to the clinic today to perform an epidural blood patch.He also accessed the pump pocket via a needle and syringe.The physician aspirated about 38 mls of yellow and amber fluid from the pump pocket.The physician stated he was planning to follow up with patient next week.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.Diagnostics/troubleshooting performed included abdominal binder postoperatively and through healing of wounds, aspiration of fluid in pocket.The issue was not resolved at the time of report.The physician stated to patient that if the symptoms do not resolve he would consider explanting pump and catheter.The physician stated he would follow up as more details of the outcome became known.The patient's weight and medical history were asked but were unknown.The status of the patient at the time of the event were "alive - no inj ury".

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) via a company representative (rep) reporting that the issue had not resolved.The patient continued to have symptoms.The patient declined a second blood patch procedure.The physician had scheduled a revision for friday (b)(6).He stated he planned to look for the csf leak.He also stated that he may explant the system and let the patient heal.The information was received yesterday, (b)(6) 2023.

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 company representative (rep) reported the explanted portion of the catheter had been discarded.

Manufacturer Narrative

Continuation of d10: product id 8780 serial# (b)(6) implanted: (b)(6) 2023 explanted: (b)(6) 2023 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 received from a company representative (rep) stated the patient continued to have headaches, nausea, dizziness, tinnitus, and general feeling of being unwell since the revision that occurred a couple months ago.The patient decided to have an explant performed.The patient was brought in for surgery on (b)(6) 2023.During the procedure 12 ml of yellow fluid had been aspirated from the pump pocket.They used a refill kit to remove 16 ml of hydromorphone 1 mg/ml and bupivacaine 5 mg/ml from the pump.The expected volume had been 16.9 ml.The pump was then filled with normal saline.The surgeon then incised over the anchor and catheter entry point.29.2 cm of the distal spinal segment and anchor had then been removed.The remaining spinal segment and pump segment remained attached to the pump.The physician commented that they could see a pseudomeningocele.This was removed and the fascia was tied together and a blood patch was performed.The pump was then set to minimum rate and the physician planned to let the patient heal for several months and may place a new catheter at a later date.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16655057
• MDR Text Key: 312415334
• Report Number: 3004209178-2023-04325
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 03/31/2023; 04/11/2023; 04/24/2023; 04/26/2023; 07/14/2023; 07/17/2023
• Supplement Dates FDA Received: 04/12/2023; 04/13/2023; 04/25/2023; 04/27/2023; 07/17/2023; 07/18/2023
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female