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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Diaphoresis (2452); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2015 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: 09-apr-2017, 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 consumer and healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal unknown baclofen 2,000 mcg/ml at 726.7 mcg/day currently via an implanted pump for intractable spasticity/head/brain injury.It was reported the intrathecal baclofen patient was changing the concentration and want to do a bridge bolus.It was noted two days ago the patient started having severe spasticity, itching, lost of appetite, sweating, spasms and went to the emergency room (er).The patient came into the clinic today to have a pump filled and checked.It was reported they went to aspirate the pump and we're expecting 16.5 cc's but could only get 0.5 cc's out.It was noted they were worried that the pump was leaking, and caller stated that the patient stated before that had happened to them but had no more information.It was reported that they needed to fill the patient's pump but only had 500 mcg/ml when the pump currently had 2000 mcg/ml of baclofen.The hcp reported that the last refill was on 2022-dec-14 and the patient was doing great until two days ago.The patient had not had any heating therapies or no alteration changes.It was reported that they would look to do a dye study and to do a bridge bolus.The caller would call back once they decided what they were going to do for the next steps.Technical services (ts) also sent over the removing system content removal in case they could aspirate from the catheter access port (cap) and decided they wanted to do that route.The rep called back with additional information, and it was reported that they filled the pump today with 20 ml of 500 mcg/ml baclofen.The hcp had aspirated the catheter successfully, with no issues.They then did a dye study where the doctor felt everything looked good, but thought it was "hard to push the dye but it did go and did show and on x-ray everything looked normal." after the dye study they completed a system contents removal procedure to get the 500 mcg/ml drug to the catheter tip.The pump was programmed at the same daily dose of 726.7 mcg/day and they programmed a one-time bolus of 25 mcg.The rep mentioned that the tablet now showed a pump replacement date of december 2026 where it had been february 2029 before.It was reviewed that this was due to the relatively high flow rate with the lower concentration drug.The patient was scheduled to have the pump filled again next week (2023-mar-01) where they plan to switch back to 2000 mcg/ml of baclofen.It was again reported that the patient experienced withdrawal symptoms and that he started having increased spasticity two days ago.It was noted the pump site was "very puffy and very swollen.".

Event Description

Additional information was received from a healthcare provider via a company representative who reported that the cause for the volume discrepancy had not been determined.No pump leak was confirmed; no cause for the withdrawal symptoms was determined; and no cause for the difficulty pushing dye during the dye study was determined.No additional actions/interventions had been taken.The event was considered resolved, and the patient was doing well.

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: 16456865
• MDR Text Key: 310533515
• Report Number: 3004209178-2023-02767
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• 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: 03/07/2023
• Date Device Manufactured: 06/02/2022
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 84 KG