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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problems Abdominal Pain (1685); No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving fentanyl 2000 mcg for a total dose of 1552.14119 mcg/day, bupivacaine 20 mg for a total dose of 15.52141 mg/day, and hydromorphone 1.3 mg for a total dose of 1.00889 mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2020 reservoir volume aspirated was beyond the 25% acceptance indicating a volume discrepancy.No action was taken.The outcome of the event was noted as ongoing.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 was related to programming/refill.The event date was (b)(6) 2020.No further complications were reported.

Manufacturer Narrative

Product id 8782, serial# (b)(4), implanted: (b)(6) 2015.Product type catheter product id 8784, serial# (b)(4), implanted: (b)(6) 2015.Product type catheter.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 the outcome of the event was updated to ongoing.It was noted on (b)(6) 2020 a catheter access port (cap) study was performed and failed.It was noted there was a catheter occlusion.System replacement was planned for (b)(6) 2020 no further complications were reported.

Manufacturer Narrative

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 the entire system was explanted/replaced on (b)(4) 2020.No further complications were reported.

Manufacturer Narrative

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 16.5 mls of solution was aspirated and discarded per protocol.Upon interrogation, the reservoir volume was 8.1ml.A catheter dye study (cds) was scheduled for (b)(6) 2020.No further complications were reported.

Manufacturer Narrative

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 the patient was hospitalized from (b)(6) 2019 through (b)(6) 2019.On (b)(6) 2019, the patient reported increased pain in abdomen.The pump was reprogrammed where the hydromorphone was increased on (b)(6) 2019 and on (b)(6) 2020.The clinical diagnosis was increased abdominal pain.The event required in patient or prolonged hospitalization.The etiology of the event (increased abdominal pain and hospitalized) indicated the relationship of the event to the device or therapy was possibly related no further complications were 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) via a clinical study reported the outcome of the event resolved without sequelae on (b)(6) 2020.No further complications were reported.

• 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: 9672018
• MDR Text Key: 177826166
• Report Number: 3004209178-2020-02633
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/06/2020

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: 05/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 02/18/2020; 03/19/2020; 03/27/2020; 07/03/2020
• Supplement Dates FDA Received: 02/05/2020; 02/19/2020; 03/19/2020; 03/27/2020; 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 81