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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020 product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 21-dec-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving baclofen (500 mcg/ml at 154.38 mcg/day) via an implanted pump.The patient reported that since implant, she had thought there was something wrong with the catheter and where the catheter goes into the spine because she had been having problems or issues with her legs.Per the patient, her doctor was aware.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, 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 via the manufacturing representative (rep).The rep was not aware if the patient's baclofen withdrawal symptoms and sciatic pain resolved.It was reported the catheter was not returned, it was apparently disposed of by the healthcare provider.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2021 product type catheter.H1 update: the type of reportable event was updated from previously being a reportable malfunction to now a reportable serious injury regarding additional information received.H6 update: the previously applied imf code f11 is no longer applicable.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 via a healthcare provider.It was reported that there was a possible catheter issue.Imaging and magnetic resonance imaging was indicated (results of tests not specified).The patient¿s weight was provided.Additional information was later received from a healthcare provider and consumer via a company representative on 2021-jan-18.The patient had a history of cerebrospinal vascular accident (cva) and previous falls.The patient was also currently in a rehabilitation facility, post a left hip replacement.It was noted that the patient stated they experienced baclofen withdrawal that began approximately one week after implant.Since (b)(6) 2020 the patient had intermittent pump dose adjustments.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient indicated they had sustained a fall due to baclofen withdrawal.The fall resulted in a fractured left arm (patient was in a cast), fractured left hip, and injury to her left clavicle.It was further noted that the patient had a hip replacement surgery approximately a week ago during the week of (b)(6) 2021 (specific date was unable to be provided).The company representative was not aware of any diagnostic tests or troubleshooting that occurred prior to the catheter revision surgery on (b)(6) 2021.The physician removed the patient¿s existing catheter that was previously implanted on (b)(6) 2020 and replaced the entire catheter.It was noted that the catheter did not have a leak or tear, but the physician thought it maybe have been causing the patient¿s sciatic pain.Post-operation, the physician ordered a single bolus of 75 mcg to infuse, after a priming bolus was completed.It was unknown if the issue was resolved as of (b)(6) 2021.The pump was administering baclofen with concentration 500 mcg/ml at a dose rate of 230 mcg/day.

• 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: 11107906
• MDR Text Key: 224754724
• Report Number: 3004209178-2021-00015
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 45