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 Problem Pain (1994)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot#: (b)(4), ubd: 12-apr-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal bupivacaine 18.7 mg/ml at 7.5 mg/day, dilaudid 1.2 mg/ml at 0.48 mg/day, and compounded baclofen 850 mcg/ml at 340 mcg/day via an implanted pump.It was reported the patient was experiencing systemic pain and the managing physician felt a higher catheter placement would help address the patient¿s systemic pain.It was further reported the patient's managing physician had been looking for surgeons who were willing to implant the catheter on this patient in the upper thoracic area.A neurosurgeon agreed to do that.It was noted there were no issues with the existing catheter per the managing physician.This was documented via a dye study, and the managing physician also stated the expected versus actual residual volumes were within normal limits.The patient was kept on the same infusion rate after priming the catheter length.It was noted the neurosurgeon used a midas rex to access the t 7¿8 inner space as the patient had hardware in his spine and there was too much scar tissue in the lumbar area to place a needle.The catheter tip was threaded up to t4 posterior level.After tunneling the new 8782 catheter segment from the t 7¿8 entry site down to the lumbar site, the catheter was connected to the existing 8780 segment that ran from the pump pocket site to the lumbar incision site.The neurosurgeon then accessed the catheter access port with a 24 gauge non-coring needle and easily withdrew cerebrospinal fluid (csf) with no air bubbles.There were no environmental/external/patient factors that may have led or contributed to the issue.On (b)(6) 2022, the neurosurgeon spliced a new spinal segment 8782 onto the existing 8780.It was unknown if the issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿.The patient¿s other medication included: xanax, baclofen oral prn, diphenhydramine, pregabalin, zanaflex, oxycodone.The patient¿s medical history included: spinal cord injury on (b)(6) 2017, spinal fusion, spinal hardware, pressure sore repaired with skin flap, colostomy, and suprapubic catheter.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2019 explanted: (b)(6) 2022 product type catheter h#: the catheter was returned and no significant anomalies were found.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: 13290473
• MDR Text Key: 284347576
• Report Number: 3004209178-2022-00832
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• 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: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Weight: 72 KG