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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Failure to Disconnect (2541); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Calcium Deposits/Calcification (1758); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id neu_unknown_cath lot# unknown serial# implanted: explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown, udi#: unknown.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

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen with concentration 2000 mcg/ml at a dose rate of 395.4 mcg/day via an implantable pump.It was reported that during a routine pump replacement, the pump connector of catheter was removed with slight difficulty.Reattachment was considered routine and the surgeon had commented to all going as planned.The patient was admitted a few days later to emergency room (er) with withdrawal symptoms.A dye study was performed and showed the catheter to pump connection was leaking.The date of the dye study was unknown.There were no known factors that may have led or contributed to the issue.The issue was not resolved as of (b)(6).Surgical intervention was planned to occur on (b)(6).The patient was without injury regarding their status as of (b)(6).The patient's medical history was unknown or would not be made available.

Manufacturer Narrative

Continuation of d10: product id 8780, implanted: (b)(6) 2016, explanted: (b)(6) 2023, 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 foreign healthcare provider via a company representative.The serial/lot number of the model 8781 catheter was unknown.It was further noted that calcification was noticed around the pump connector during the routine pump replacement on (b)(6) 2023.The surgeon attempted to clear the pump connector and subsequently attached to the new pump without issue.A verbal confirmation during the surgery was had, where surgeon said ¿everything went well¿.However, the catheter was later replaced as planned on (b)(6) 2023.Regarding if catheter damage occurred as a result of the report of difficulty encountered during disconnect of the catheter from the pump at the routine pump replacement procedure, it was noted that they could not confirm, but surgeon commented that was likely the case.Regarding if the cause of the leaking at the connection was determined, it was noted that it was, and that a dye study had been performed under ct on (b)(6) 2023.The leaking at the pump catheter connection and withdrawal symptoms had been resolved.The patient was doing well and had been discharged from the hospital a few days post operation after the catheter revision.The healthcare provider had refused return of the catheter and had discarded the device.

• 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: 16752869
• MDR Text Key: 313433548
• Report Number: 3004209178-2023-05125
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Date Device Manufactured: 10/18/2022
• 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....; SEE H10....
• Patient Outcome(s): Hospitalization; Required Intervention