MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780 , serial#: (b)(4) , implanted: (b)(6) 2018, partially explanted: (b)(6) 2021 , product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-jul-2020, udi#: (b)(4) if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing dilaudid with concentration 15 mg/ml at a dose rate of 2 mg/day via an implantable pump for spinal pain.It was reported that the event occurred during a procedure.  the catheter would not aspirate via the side port.  there were no environmental/external/patient factors that may have led or contributed to the issue.  the catheter was revised.  only a portion of the pump segment (20 cm) was explanted and replaced.The catheter was to be returned to the manufacturer.The issue was resolved.  the patient was without injury regarding their status as of (b)(6) 2021.The patient's weight and medical history were unknown.

Event Description

Additional information was received via a consumer.It was reported that the patient missed his pump refill in (b)(6) 2020 (specific month and year reported only).The clinic never called him to inform him of the appointment.In (b)(6) 2020 the patient called the clinic and told them he was in so much pain he was nearly in tears.The date (b)(6) 2020 is considered an approximate date of event (specific month and year known only).They rushed the patient to the clinic the next day and the physician told him he was not able to remove any medication from the catheter.The patient was also told that their catheter must be kinked.By (b)(6) 2020 the patient was "really getting bad, couldn¿t walk, and couldn¿t do much of anything.He was having a lot of pain and hurting really bad.In (b)(6) 2021 they found the kink in the catheter the pump administered dilaudid and bupivacaine.Drug concentrations and dose rates were unknown.

Manufacturer Narrative

H6 update: the previously applied patient code e2403 (c76143) is no longer applicable.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: analysis of the catheter revealed catheter body; kinked observed; damage to transition tube 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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11286556
• MDR Text Key: 230517739
• Report Number: 2182207-2021-00208
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR