MAUDE Adverse Event Report: MEDTRONIC 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 Emotional Changes (1831); Pain (1994); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8782, serial#: (b)(4), implanted: (b)(6) 2021 explanted: 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: 10-mar-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving fentanyl (2000 mcg at 549.49816 mcg/day), bupivacaine (20 mg at 5.49498 mg/day), and morphine drug, unknown (3.5 mg at.9891 mg/day) via an implantable pump for unknown indications for use.It was reported that on 2021-oct-05 the patient called stating the pump was not working as they could not feel boluses.  on (b)(6) 2021 the patient was in a car accident 3 weeks ago and has not "felt a single bolus since".  it was noted the patient was miserable and emotional.  on (b)(6) 2021 a catheter dye study (cds) was ordered and scheduled for (b)(6) 2021.  oxycodone was prescribed.  on (b)(6) 2021 the catheter dye study failed as they were unable to aspirate the catheter and noted the catheter was occluded.  catheter revision surgery was required.The outcome was noted as ongoing.  the device diagnosis was catheter occlusion.  the clinical diagnosis was inadequate pain relief.  the event resulted in prolongation of existing hospitalization.  the etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2021.

Event Description

Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep) reported the patient began feeling less pain relief from their medication on (b)(6).They did a dye study on (b)(6) 2021, which failed as they were unable to aspirate the catheter and scheduled the patient to have a revision today (on (b)(6) 2021).Upon opening up the patient, they were unable to aspirate the catheter.The hcp removed the entire existing 8782 spinal segment and replaced it with a new 8782 spinal segment on (b)(6) 2021.They were then able to successfully aspirate once the system was connected.No further changes were made.It was noted that the hcp went from a dose per day of 549.5 mcg/day of fentanyl to a dose of 100 mcg/day following the revision on (b)(6) 2021.The patient's status was alive-no injury.It was noted the issue resolved without sequelae on (b)(6) 2021 (time of report).Medications included aspirin 81 mg tablet, atorvastatin 20 mg tablet, cephalexin 500 mg capsule, gabapentin 600 mg tablet, hibiclens 4% topical liquid, lantus 100 unit/ml, lisinopril 10 mg tablet, mupirocin 2% topical ointment, narcan 4 mg/actuation nasal spray, novolog 100 unit/ml subcutaneous solution, oxycodone 20 mg tablet, oxycodone 5 mg tablet, and tylenol arthritis pain 650 mg tablet.

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.

Manufacturer Narrative

H3: the catheter was returned, and analysis observed a kink in the catheter body.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

G3: please note: the previous mdr was sent with an aware date of 2021-jan-08 when the correct aware date should be 2022-jan-08.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) via a clinical study reported on (b)(6) 2021 catheter revision surgery occurred.On (b)(6) 2021 the patient presented with intense pain.The device was reprogrammed where the fentanyl was increased to 150 mcg and programmed to8 boluses at 25 mcg each.On (b)(6) 2021 the device was reprogrammed where the fentanyl was increased to 150 mcg and boluses by 10 mcg each.On (b)(6) 2021 the device was reprogrammed where the fentanyl was increased to 150 mcg/day and boluses to 45 mcg each.On (b)(6) 2021 it was noted the previous increases were not helpful, reported inadequate pain relief and they cannot feel boluses.On (b)(6) 2021 it was noted that the last increase provided benefit.The bolus that was delivered in clinic provided relief.On (b)(6) 2021 the device was reprogrammed where the fentanyl was increased by 100 mcg and boluses to 65 mcg.The outcome of the event resolved without sequelae on (b)(6) 2021.

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.

• 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: 12623368
• MDR Text Key: 276129055
• Report Number: 3004209178-2021-15273
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 01/08/2022; 01/08/2022; 01/27/2022
• Supplement Dates FDA Received: 11/11/2021; 01/11/2022; 01/11/2022; 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 93 KG