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

Model Number 8637-40

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

Product id 8781 lot# serial# (b)(4) implanted: (b)(6) 2023 explanted: (b)(6)2023 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: (b)(6) 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.

Event Description

Information was received from a healthcare professional (hcp) via a company representative (rep) regarding a patient receiving dilaudid 1 mg/ml at 0.4 mg/day via an implantable pump for chronic pain.It was reported the patient developed a burning sensation of their right leg after the first titration up of the drug on (b)(6)2023.And the sensation spread to their left leg after the second titration on (b)(6)2023.The patient stated they were told the catheter tip may be up against a bundle of nerves.An mri took place on (b)(6) 2023.A catheter revision occurred of the spinal segment and a new spinal segment was placed, and the tip had been moved from the previous location of t7 to t9.At the time of this report the issue had been resolved and the patients status was alive - no 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

Additional information received from the company representative stating that the hospitalization was caused by the pain due to the increase in medication.It created the left sciatic like pain.The healthcare provider thought the entry location of the catheter may be the caused of the pain and moved the entry level of the catheter from l2/3 to t11/12.That is all the information that was provided at the time.

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 fromthe company representative.The patient¿s symptoms were resolved after catheter revision.They went for drug titration appointment to their hcp on (b)(6) 2023.Increased dose from dilaudid 0.4 to 0.6 mg but developed pain again.The patient describes as left sciatic pain in the buttocks area.It was different from before.They were hospitalized on (b)(6) 2023.The neurosurgeon gave her the option of complete explant or to attempt to reposition catheter one last time.If the catheter is irritating the nerves, then an explant will be necessary next time.The patient opted to have catheter repositioned one more time.

Event Description

The following information previously submitted in mdr fu1 and mdr fu2 is not part of the event in this manufacturer¿s report, but rather belongs with the information reported in 3004209178-2023-05707: [mdr fu1 - additional information was received from the company representative.The patient¿s symptoms were resolved after catheter revision.They went for drug titration appointment to their hcp on (b)(6) 2023.Increased dose from dilaudid 0.4 to 0.6 mg but developed pain again.The patient describes as left sciatic pain in the buttocks area.It was different from before.They were hospitalized on (b)(6) 2023.The neurosurgeon gave her the option of complete explant or to attempt to reposition catheter one last time.If the catheter is irritating the nerves, then an explant will be necessary next time.The patient opted to have catheter repositioned one more time.] [mdr fu2 - additional information received from the company representative stating that the hospitalization was caused by the pain d ue to the increase in medication.It created the left sciatic like pain.The healthcare provider thought the entry location of the catheter may be the caused of the pain and moved the entry level of the catheter from l2/3 to t11/12.That is all the information that was provided at the time.].

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.

• 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: 16689816
• MDR Text Key: 313207609
• Report Number: 3004209178-2023-04628
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• UDI-Public: 00763000634100
• 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
• Report Date: 05/01/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2024
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/15/2023; 04/18/2023; 05/01/2023
• Supplement Dates FDA Received: 04/18/2023; 04/22/2023; 05/01/2023
• Date Device Manufactured: 12/23/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 113 KG