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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8709 lot# serial# (b)(4).Implanted: (b)(6) 2007.Explanted:.Product type catheter product id 8578.Lot# serial# (b)(4).Implanted: (b)(6) 2020.Explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 04-oct-2008, udi#: (b)(4); product id: 8578, serial/lot #: (b)(4), ubd: 21-feb-2021, 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 healthcare provider via a company representative regarding a patient receiving baclofen 400mcg/ml via an implantable pump.It was reported the patient noticed a change in therapy.The environmental, external or patient factors that may have led or contributed to the issue was noted as ¿n/a¿.The diagnostics and troubleshooting performed was a cap (catheter access port) procedure was done today, negative catheter aspiration.The actions and interventions taken to resolve the issue was surgical intervention would be scheduled, not scheduled yet.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.

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.

Event Description

Additional information was received from a company representative.It was reported that the rep wanted to do an advanced prime bolus and the programmer stated to call into technical support.Technical support reviewed the situation was a catheter revision and that the pump wasn't replaced.Technical services reviewed that a prime of the catheter volume would be needed.The rep stated he was in the middle of the catheter revision case and did not have a lot of time.The rep stated that the patient had a complete catheter replaced and the catheter aspirated after connection to the pump.The rep stated the baclofen (400 mcg/ml) was going to be changed to 25 mcg/day to 75 mcg/day.A different company representative (rep) noted the catheter was replaced with a new 89.3 cm ascenda catheter, volume 0.196 ml.The rep noted the patient likely had not been getting drug due to the catheter issue.It was reported it was an hour since the pump was attached to the new catheter.The rep noted that they had to assist with programming issues, as they had issues with a communicator communicating with the pump.The rep was not at the case, but was able to resolve the communicator/communication issue.

• 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: 15119485
• MDR Text Key: 296759001
• Report Number: 3004209178-2022-09580
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• 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: 09/26/2022
• Date Device Manufactured: 10/29/2019
• 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 Age: 85 YR
• Patient Sex: Female