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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8731sc lot# serial# (b)(6).Implanted: (b)(6) 2013 explanted: (b)(6) 2014 product type catheter p roduct id 8709 lot# serial# (b)(6) implanted: (b)(6) 2004 explanted: (b)(6) 2014 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(6) , ubd: 21-mar-2014, udi#: (b)(4) ; product id: 8709, serial/lot #: (b)(6), ubd: 14-oct-2006, 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.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 patient's representative regarding a patient receiving unknown medication via implanted infusion pump.It was reported that the patient no longer had their two pain pumps.The catheter was left inside of the patient near their spine as it was explained by their healthcare provider (hcp) that it was safer to leave it in than take it out.The patient's representative reported that it was not giving medication when it was supposed to.The catheter was left in and was now deteriorating.No further information was reported.

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 received from a healthcare professional (hcp) reported the patient had presented to the emergency room in (b)(60) 2023 with symptoms of opioid withdrawal.An x-ray had been performed and found the catheter had likely migrated out of the spinal canal and into the epidural space and the patient had clearly been no longer receiving efficacy.The physician reported they had no knowledge of the catheter deteriorating as they believed that catheters implanted in 2004 were designed to be left in the patient.At the time of the patient experiencing withdrawal they had been evaluated by a spine surgeon and offered a further extension on her fusion if the patient had stopped smoking, to which the patient initially agreed.The patient had then been started on oral medication.When the physician saw the patient again in (b)(6) 2013 they had been unsuccessful in tobacco cessation and the decision had been made by the physician to no longer perform intrathecal pump implantations or revisions for the patient.The patient had then requested referrals for other doctors to receive a revision and had been unsuccessful in finding one.The patient then requested to have the system removed in (b)(6) 2014.During the explant procedure the surgeon attempted to remove the catheter but tension had caused it to snap from either end.At that time the surgeon made a medical decision to leave the catheter in the patient.The physician stated the explanted pump and portion of catheter were likely destroyed at the time of explant.

• 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
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17021204
• MDR Text Key: 316144409
• Report Number: 3004209178-2023-07444
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/14/2023
• Date Device Manufactured: 09/14/2009
• 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 Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG