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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2008, product type: catheter.Product id: 8709sc, serial/lot #: (b)(4), ubd: 24-oct-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen, morphine, and bupivacaine via an implanted pump.It was reported that the patient¿s pump was replaced on (b)(6) 2020 due to end of life.During the procedure, the catheter aspirated; the pump was primed after; and the patient was sent home doing good.The patient returned later with signs/symptoms of baclofen withdrawal.There were no environmental, external, or patient factors that may have led or contributed to the issue.A dye and rotor study were performed on (b)(6) 2020 and everything looked okay.They also put new drug in the pump to rule that out.A dye study was performed again on (b)(6) 2020 and everything looked okay, and there were no pump alarms.The doctor decided to replace the catheter.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.The patient was scheduled for the catheter replacement on (b)(6) 2020.

Manufacturer Narrative

Continuation of d10: product id 8709sc serial# (b)(6) implanted: (b)(6) 2008 explanted: 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 a healthcare provider (hcp) via a company representative on 2020-dec-18.It was reported that the old catheter was "pretty scarred in the back and there was a lot of extra loops that were bent." the doctor thought it could have been kinking intermittently.He replaced the whole catheter.He thought it may have had a small leak as well.He discarded the catheter.

• 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: 11026644
• MDR Text Key: 222002341
• Report Number: 3004209178-2020-22074
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR