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

Model Number 8637-20

Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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

Information was received from a patient who was receiving dilaudid and a second unknown medication via an implantable pump.The indication for use was malignant pain and spine/back.It was reported that the patient was calling to see if the manufacturer could remotely tell if the pump was working.They were having feelings of withdrawal for about 2 days, like the last time when they ran out of medication completely while they were in the hospital about a year ago.They used their personal therapy manager (ptm) and that was successful.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.They stated they were allergic to dilaudid but it was in the pump.Additional information was received from the healthcare provider who indicated that the pump was interrogated and no issues were found.It was reported that the patient was referred to a different healthcare provider for the possibility of a kink.Additional information received on 10-apr-2023 from the patient who reported they had to replace the pump because their ¿body rejected it¿.The patient stated they went to the hospital and ¿fibers grew through the pump and through the line and stopped it.It broke in october 2021.¿.

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 company representative who clarified the patient¿s report that ¿fibers grew through the pump and through the line and stopped it¿.Per the reporter, the notes state the catheter would not successfully aspirate, therefore, it was replaced with a new one.The pump was replaced due to medical judgement by the physician.There was no issue with the pump.

Manufacturer Narrative

Continuation of d10: product id 8781, serial# (b)(6), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8781, serial/lot# (b)(6), ubd 2020-10-18, 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

Additional information was received from a healthcare provider (hcp) via operative notes.The patient was admitted on (b)(6) 2021 and discharged on (b)(6) 2021.The date of surgery was (b)(6) 2021.The patient¿s pre-operative and post-operative diagnoses was chronic pain syndrome and post-laminectomy syndrome, not elsewhere classified.The surgical procedure performed was ¿implant/replace device for intrathecal/epidural drug¿ and ¿implant/revise intrathecal/epidural catheter for long-term medications without laminectomy¿.During the procedure, the pump pocket was opened.An attempt was made to aspirate the side port and there was no return of cerebrospinal fluid (csf).The catheter was then disconnected and dissected free from the pocket site.It was then ¿amputated¿ and there was no spontaneous flow of csf.The lumbar paraspinal incision was then opened.The catheter was exposed subcutaneously and pulled through.The fascia and anchor were exposed.The anchoring sutures were released and removed.There was still no flow of csf.The catheter was then withdrawn from the spinal canal.There was no flow of csf at the tract in the fascia.The fascia was then repeatedly oversewn.A tuohy needle was then introduced into the thecal sac at the l2-l3 level.The stylet was withdrawn, and a new intrathecal catheter was inserted and navigated cephalad to the t8 level.A silk pursestring suture was placed at the needle fascial exit site.The tuohy needle and intrathecal catheter stylet were withdrawn.The anchor was advanced over the catheter and deployed through the fascia.The eyelets were then secured to the fascia.The pursestring suture was deployed.Several additional sutures were utilized to further secure the anchor to the fascia.The tunneling device was then passed between the 2 incisions and a proximal catheter pulled through.The 2 catheters were trimmed and then married together at the lumbar incision.A tuohy needle was then introduced into the epidural space at l2-l3 percutaneously.Entrance into the epidural space was confirmed by the loss of resistance to air technique.An epidural blood patch was performed, and the needle withdrawn.The proximal catheter was then secured to a new intrathecal pump.The side port was aspirated and injected verifying patency.The new pump was then placed back into the pocket site and secured with sutures.The wounds were closed, and sterile dressing were applied.

Event Description

Additional information was received from a company representative.The company representative was in the healthcare provider¿s office, and there was not any documentation in regards to the patient¿s body rejecting the pump or catheter.

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.

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 company representative.The company representative was in the healthcare provider¿s office, and there was not any documentation in regards to the patient¿s body rejecting the pump or catheter.

• 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: 16767161
• MDR Text Key: 313558948
• Report Number: 3004209178-2023-05227
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2023
• Date Device Manufactured: 02/04/2019
• 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....".; "SEE H10....".
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female