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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Loss of consciousness (2418); Cognitive Changes (2551); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780 serial# (b)(4) implanted: (b)(6) 2015.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 09-jan-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen (2000 mcg/ml at 577.6 mcg/day) via an implanted pump.It was reported that the patient had their pump replaced in (b)(6) 2021.The patient started experiencing symptoms of withdrawal and symptoms of overdose immediately following the pump replacement and the symptoms had continued since then.A dye study was successfully completed in (b)(6) 2021.On the evening of the dye study in november, the patient stated that he blacked out and woke up 18 hours later.He stated that he alternates between being very spastic and very loose.When he is very spastic, his mental status is altered as well.He had been in and out of the hospital and had been through a number of diagnostic tests with no results.Another dye study was attempted on (b)(6) 2022.The catheter was successfully aspirated, but the physician was unable to push any dye, so the dye study was aborted at that point.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.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2015, 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.

Event Description

Additional information was received that the patient was experiencing fluctuating worsening spasticity and then episodes of decreased tones.The managing healthcare provider (hcp) had ordered a fluro dye study several weeks ago and it was shown there was obstruction since they were not able to inject anything.They were thinking there was possibly a granuloma however they did not think it was a kink.The soonest appointment they had set up was sometime in april to revise the catheter.Troubleshooting was not required.They would work on getting the catheter revised.

Event Description

Additional information received indicated the catheter was replaced.

Manufacturer Narrative

Continuation of d10: product id 8780, lot# , serial# (b)(6), implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type: catheter.H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2022 product type catheter h3 ¿ analysis of the catheter found ¿catheter body ¿ compressed area¿ and ¿catheter body ¿ damage to transition tube¿ 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
• 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: 13658730
• MDR Text Key: 288675155
• Report Number: 3004209178-2022-02748
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2022

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: 07/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 03/10/2022; 03/14/2022; 06/01/2022
• Supplement Dates FDA Received: 03/15/2022; 03/28/2022; 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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...."
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male