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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)

Patient Problems Granuloma (1876); Muscle Weakness (1967); Pain (1994); Malaise (2359); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter.Product id: 8780, serial/lot #: (b)(4), ubd: 28-sep-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving bupivacaine (20 mg/ml at 4.143 with all boluses mg/day) and dilaudid (hydromorphone) (20 mg/ml at 4.143 with all boluses mg/day) via an implantable pump for non-malignant pain.It was reported that the patient's last refill was on (b)(6) 2020 (the patient gets refilled every 12-13 weeks) and the healthcare provider (hcp) was expecting to pull out 5 ml however they actually pulled out 15 ml.  it was noted around that time was when the patient started experiencing more pain, feeling bad in general, had weakness in legs, stumbling around, pain in legs, not being able to stand for more than 2-3 seconds, needing to hold on to something in order to have balance, and just walking issues in general.The hcp told the patient to give it 6 weeks before they addressed the issue again, however, the patient had been doing his own research and was concerned that he might have a granuloma due to weakness in leg symptoms.It was reported initially the patient just thought the pain/not feeling well w as just related to withdrawal and the weakness in legs might have been related to his artery blockage (patient was currently working with cardiologist and might need bypass).It was noted the patient was concerned and wanted to know what he should do.  the patient was redirected to the hcp.

Event Description

Additional information was received from a healthcare provider (hcp) who reported that the patient¿s pump and catheter were replaced due to a catheter problem.The hcp was unsure what was found with the catheter and stated the pump was replaced due to nearing eos (end of service).

Manufacturer Narrative

Continuation of d10: product id: a820, serial#: unknown, product type: software.Product id: 8780, serial# (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2021, 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 the healthcare provider indicated that a granuloma was not confirmed.It was reported that the cause of the catheter file was likely due to a catheter occlusion, the explanted device was currently in the pathology department.

Manufacturer Narrative

Continuation of d10: product id a820, serial# unknown, explanted: product type software product id 8780, serial# (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2021, 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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11109201
• MDR Text Key: 225317125
• Report Number: 3004209178-2021-00059
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 112