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

Model Number 8637-20

Device Problem Infusion or Flow Problem (2964)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2011, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 08-may-2021.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional (hcp) via manufacturer representative (rep) regarding a patient receiving intrathecal baclofen (concentration/dose unknown) via an implantable pump.It was reported that the patient did not feel like the pump helped as much.Dye study was performed.Healthcare provider (hcp) was not able to get the fluid back from the catheter access port (cap).The patient was referred to their hcp for a follow up.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative who reported that a catheter dye study was repeated in the or (operating room) and again it was determined that the catheter was not patent enough to provide adequate therapy.The patient was then placed in a lateral position and the pump pocket site was opened.Once the catheter was disconnected from the pump, the catheter was dripping fluid.The hcp then replaced the pump segment of the catheter and the pump.Once the new catheter piece was attached to the new pump another dye study was done and it was found to be a successful study and patient therapy was resumed.

Manufacturer Narrative

Continuation of d10: product id 8780, serial# (b)(6), implanted: (b)(6) 2011, explanted: (b)(6) 2022, 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.

Manufacturer Narrative

Product id 8780, serial# (b)(6), implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type catheter h3: analysis of the catheter revealed catheter body, compressed area.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

Product analysis (b)(4): analysis information -- 2022-06-13 11:11:59 cst pli# 20 product id# 8637-20 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.The returned device passed all testing in the laboratory and no anomalies were identified.Continuation of d10: product id: 8780, serial# (b)(6), implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type: catheter.Corrected the codes for the 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

Information was received from healthcare professional (hcp) via manufacturer representative (rep) regarding a patient receiving "intrathecal" baclofen (concentration/dose unknown) via an implantable pump.It was reported that the patient did not feel like the pump helped as much.Dye study was performed.Healthcare provider (hcp) was not able to get the fluid back from the catheter access port (cap).The patient was referred to their hcp for a follow up.2022-04-21 (b)(4) & attachment (rep/hcp): additional information was received from a healthcare provider (hcp) via a company representative who reported that a catheter dye study was repeated in the or (operating room) and again it was determined that the catheter was not patent enough to provide adequate therapy.The patient was then placed in a lateral position and the pump pocket site was opened.Once the catheter was disconnected from the pump, the catheter was dripping fluid.The hcp then replaced the pump segment of the catheter and the pump.Once the new catheter piece was attached to the new pump another dye study was done and it was found to be a successful study and patient therapy was resumed.2022-05-20 (b)(4) (rep): document contained no new information.

• 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: 14170949
• MDR Text Key: 290198115
• Report Number: 3004209178-2022-05079
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female