MAUDE Adverse Event Report: MDT 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 Problems Muscle Spasm(s) (1966); Overdose (1988); Malaise (2359); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 26-aug-2015, 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 via a manufacture representative regarding a patient receiving lioresal (2000 mcg/ml at around 211 mcg/day) via an implanted infusion pump.It was reported the patient's pump was replaced, on (b)(6) 2020, and after the surgery the patient became very sick and seemed to be having more spasms.It was noted the patient was overweight and had a lot of health issues so they do not known if these issues were related to the pump.The surgeon tried and could not access the sideport yesterday and then went to do a bolus and delivered more than they planned so the patient was put in the icu.The rep saw the patient last night and the patient seem fine.The patient had surgery and when they opened the pump pocket and attempted to aspirate the catheter of fluid they were unsuccessful.The pump end of the catheter was revised and aspirated freely after that.

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturer representative.It was reported that the cause of the inability to aspirate the catheter was that the catheter was notpatent.The issue was resolved and the patient was currently stable.

Manufacturer Narrative

Continuation of d10: product id 8781 lot# serial# (b)(6) implanted: (b)(6) 2014 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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10824065
• MDR Text Key: 216836306
• Report Number: 3004209178-2020-19770
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR