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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Meningitis (2389); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system.The pump was used to deliver gablofen (baclofen) 2000mcg/ml at 600mcg/day.It was reported that the patient's back incision was red.The patient had a fever and drainage at the site.The patient's cerebrospinal fluid showed possible meningitis.The pump was infected.In regards to diagnostics or troubleshooting performed, antibiotics were tried but, with the "id" of possible traces of meningitis, the doctor made the plan to wean the patient down off of the baclofen dose and explant the pump and catheters.Device explant was planned for (b)(6) 2023.The devices would be sent to infectious disease.The patient's weight and medical history were asked but were unknown.In regards to environmental, external or patient factors that may have led or contributed to the issue, nothing was reported in terms of falls or other issues or any environmental factors.At the time of this report, the issue was not resolved and the patient status was "alive-no injury".The event occurred post-operatively.

Manufacturer Narrative

Continuation of d10: product id: 8782, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter; product id: 8784, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 15-nov-2018, udi#: (b)(4); product id: 8784, serial/lot #: (b)(4), ubd: 18-apr-2020, 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.

Manufacturer Narrative

Concomitant medical products: product id 8782 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: (b)(6)2023 product type catheter pro duct.Id :8784, serial# (b)(6), implanted: (b)(6) 2018 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 provide via a company representative who reported that the system was being explanted tomorrow (b)(6) 2023).Additional information was received on 22-may-2023 at which time it was reported that the system explant occurred as planned.With regards to if the infection resolved and if not, what other actions would be taken to resolve it, it was noted that the ¿infection has resolved/and is resolving but since they found traces of meningitis, they wanted to remove the entire system¿.The csf (cerebrospinal fluid) sampling showed the ¿id of possible traces of meningitis¿.

• 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: 16970194
• MDR Text Key: 315685178
• Report Number: 3004209178-2023-06787
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• 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: 05/18/2023
• Date Device Manufactured: 03/05/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male