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

Model Number 8637-40

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving compounded baclofen 4 00mcg/ml at 106.5 mcg/day, dilaudid 15mg/ml at 4 mg/day and bupivacaine 10mg/ml at 2.66mg/day via an implantable pump.It was reported that the patient was scheduled for routine pump replacement due to eri (elective replacement indicator) 11 months.This physician routinely replaces his pumps at this time to prevent abrupt motor stall.While in pre-op, the physician performed a catheter access study but was unable to aspirate any csf.The environmental, external or patient factors that may have led or contributed to the issue was multiple medications in the pump; high drug concentrations.The diagnostics and troubleshooting performed as negative catheter access study in pre-op.The actions and interventions taken to resolve the issue was the patient was taken to the or today for routine pump replacement.The physician started by opening up the pump pocket and dissecting out the existing pump and proximal pump segment.Once the pump was removed from the pump pocket, the physician again attempted to aspirate from the catheter access port, but was again unsuccessful.The old pump and proximal segment were removed and placed on the sterile field.The physician then proceeded to use preservative free normal saline and a 1 ml syringe to flush the catheter.After multiple flushes, the physician was able to aspirate from the catheter and csf was seen dripping freely from the catheter.The physician then proceeded to reattach the proximal pump segment in the new pump.A final aspiration was done to confirm patency of the catheter.Because it is unknown how long the catheter was obstructed or the exact cause of the obstruction, the patient¿s intrathecal drug concentrations and dosing were subsequently reduced in order to prevent symptoms of drug overdose/toxicity.The new drug concentrations were as follows: dilaudid 5 mg/ml, bupivacaine 3.33 mg/ml, and clonidine 133.3 g/ml.The new daily dosing was reduced to the following: dilaudid 2 mg per day, bupivacaine 1.3 mg per day, and clonidine 53.28 g per day.The issue was resolved at the time of the report and it was noted the healthcare provider would not have any further information regarding the event.

Manufacturer Narrative

Concomitant medical products: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type catheter, product id 8578, serial# (b)(4), implanted: (b)(6) 2016.Product type catheter.Other relevant device(s) are: product id: 8709sc, ubd: 02-aug-2012, udi#: (b)(4), product id: 8578, ubd: 16-feb-2018, 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.

• 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: 15697813
• MDR Text Key: 303558976
• Report Number: 3004209178-2022-14194
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• 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: 10/25/2022
• Date Device Manufactured: 03/21/2016
• 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 Sex: Female
• Patient Weight: 82 KG