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); Infusion or Flow Problem (2964)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# hg5etse09 implanted: 2022-02-09 explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6)2023, 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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving unknown drug via an implantable pump for unknown indications for use.It was reported that at refill today, (b)(6) 2023, 23 ml's were removed when 8 ml's were expected.The patient reported to the doctor increased pain.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.A roller and dye study were completed on (b)(6) 2023.The roller study x2 with expected rotation.The hcp was unable to aspirate the catheter.The hcp was going to refer the patient to another hcp for a catheter revision.The issue was not resolved at time of report.The patient's weight and medical history were asked, but unknown.The patient's status at time of report was alive no injury.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2022 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 was received from a healthcare provider (hcp) via a manufacturer representative (rep).Hcp reported that the patient had been having issues "on and off for a while" with their catheter.A definitive timeline for the issues was not given.The hcp re-reported previously documented information about the roller studies and dye study.The patient also reported suboptimal pain control.The hcp believed that the catheter occlusion could have been related to a pseudomeningocele.The patient was taken to the operating room today ((b)(6) 2023 for a planned catheter revision.The hcp first started by opening the pump pocket.They dissected out the existing pump and proximal pump segment.The pump was disconnected from the catheter and placed on the back table, at which time there was no flow seen from the proximal segment.The hcp then attempted to use a syringe to coax some cerebrospinal fluid (csf) from the catheter, but was unsuccessful.Hcp then proceeded to cut the proximal pump segment, but there was still no csf flow from the catheter.At this time, the hcp concluded that the obstruction was in the spinal segment of the catheter.The hcp then proceeded to open up the lumbar spine incision.The proximal segment of the existing catheter was removed and discarded by the customer.The spinal segment was tied off and abandoned within the lumbar incision.The hcp was given a new catheter kit which they used to place a new catheter at the t9 level.The new catheter was tunneled to the existing pump pocket and connected to the existing pump.The pump was placed back within the existing pump pocket and the hcp performed a final catheter aspiration which had ample return of csf.The pump contained fentanyl (1000mcg/ml at 600mcg/day).The patient's weight was 94kg.The patient's medical history was asked but unknown.The patient status at the time of the report was alive with no injury.The issue was resolved at the time of the report.

• 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: 16704490
• MDR Text Key: 313024145
• Report Number: 3004209178-2023-04719
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: 00763000422615
• 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
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Date Device Manufactured: 06/23/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 94 KG