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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Therapeutic Effects, Unexpected (2099); Neck Pain (2433)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8782, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 13-aug-2021, udi#: (b)(4).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 799.43616 mcg/day, bupivacaine 20 mg for a total dose of 7.99436 mg/day, and morphine 15 mg for a total dose of 5.99577 mg/day via an implantable pump.It was reported the patient had increased pain in the cervical region on (b)(6) 2020.A syringe with increased morphine was given the same day.It was noted the issue was possibly related to the device or therapy and possibly related to the drug morphine.A catheter dye study was discussed for function and pain control.The event was noted as ongoing.The patient's weight was (b)(6).Additional information received from an hcp via a clinical study indicated that the patient still reported that they were not getting relief from the pump on (b)(6) 2020.At the last visit morphine sulfate was increased, but the patient did not notice the increase.A catheter dye study (cds) was scheduled for (b)(6) 2020.Additional information received from an hcp via a clinical study indicated that a catheter dye study (cds) was performed on (b)(6) 2020 and was normal, but it was noted that the catheter had migrated from c4 to t3.Revision was recommended, and on (b)(6) 2020 the catheter tip location was revised.The existing catheter was advanced up to "see one." the anchor was able to slide off of the catheter without the cutting tool.The collet was also removed as it was starting to have kinking memory around the edges of the collet.When the catheter was bent at the edges of the collet, it was difficult to push medication through with pressure.This bend was starting to form in the midline pocket.There were no environmental/external/patient factors that may have led or contributed to the issue.The event was considered resolved without sequelae on (b)(6) 2020.

Manufacturer Narrative

G4: date corrected to reflect the date that the reportable information was received.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 found no significant anomaly (dried drug, blood, or foreign material occlusion in the catheter body).H6: all previously reported method, result, and conclusion codes no longer apply to this event.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: 10818331
• MDR Text Key: 215597561
• Report Number: 3004209178-2020-19697
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 88