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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Dehydration (1807); High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Vomiting (2144); Numbness (2415); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8782, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.Product id: 8782, serial/lot #: (b)(4), ubd: 06-sep-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump.It was reported on (b)(6) 2021 the patient reported increased pain and unable to feel a bolus/boluses not useful with increases.A catheter dye study was performed and failed.It was noted they were unable to aspirate the catheter.No action was taken.The outcome of the event was noted as ongoing.The clinical diagnosis was increased pain and the device diagnosis was pump unable to enter/withdraw from catheter access port.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2021.No further complications were reported.

Manufacturer Narrative

Continuation of d10: product id 8781, serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type catheter product id 8782, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type catheter h3: the catheter was returned, and analysis found acceptable testing as the catheter was incomplete and returned in segments.H3: the catheter was returned, and analysis found a kink in the catheter body and a tear in the seal near the ring of the sc connector.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 received from an hcp via a manufacturer representative indicated that the patient reported numbness at the po cket site and intermittent numbness going into their legs that would make it difficult to walk.The symptoms started in (b)(6) 2020, and on (b)(6) 2021 the patient came in for signs of withdrawal.The patient's pain quality was reported as difficult to describe and severe.The patient had tried conservative treatments without resolution of symptoms.The patient was dehydrated at this visit and was given intravenous (iv) fluids.The patient was hypertensive on (b)(6) 2021 and had not been in the past.The hypertension was likely secondary to pain.The patient also had mildly low potassium as they were unable to tolerate oral medication replacement and had episodes of vomiting and nausea.It was further noted that the patient was not able to tolerate oral medication other than their pain pills with a sip of water.The patient had poor oral intake due to nausea and vomiting, and was using ondansetron without relief.Ms contin was to start after the (b)6) 2021.Appointment.On (b)(6) 2021 surgery was performed.The hcp went to the midline incision and disconnected the collet.The catheter was freely flowing with cerebrospinal fluid (csf).A test bolus was done to make sure that the pump segment was patent, and it was patent.The catheter was connected back up with a new collet and they were unable to aspirate at the side port access.The pump pocket was then opened and the catheter was disconnected and could not be aspirated.There was some tissue noted in the sutureless connector.Once the tissue was removed, the catheter still would not flow.A new pump segment was connected and the catheter did flow freely.A final side port was done and csf exited the side port as normal.The issue was considered resolved at the time of report and the surgical notes indicated that the surgery was necessary because the malfunctioning catheter was not delivering pain medication.Concomitant medications included buspar, zyrtec, valium, lasix, atarax, morphine, zofran, protonix, klor-con, zanaflex, and topamax.

Manufacturer Narrative

Concomitant medical products: product id 8782 lot# serial# (b)(6) implanted: (b)(6) 2018 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 via a company representative.The catheter components were returned to the manufacturer.As per the pump log provided, the pump administered the following medications: fentanyl (concentration: 2000.0 mcg/ml, dose rate: 399.8 mcg/day), bupivacaine (concentration: 20.0 mg/ml, dose rate: 3.998 mg/day), and morphine (concentration: 4.8 mg/ml, dose rate: 0.9594 mg/day).

Manufacturer Narrative

Continuation of d10: product id 8781 lot# serial# (b)(6) implanted: (b)(6) 2014 explanted: (b)(6) 2021 product type catheter pro duct id 8782 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: (b)(6) 2021 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(6), ubd: 2016-05-13, udi#: (b)(4).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.

• 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: 11264021
• MDR Text Key: 229884388
• Report Number: 3004209178-2021-01770
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,Followup,Followup
• Report Date: 03/26/2021

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: 01/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/02/2021; 02/08/2021; 03/25/2021
• Supplement Dates FDA Received: 02/05/2021; 02/24/2021; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 76