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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Muscular Rigidity (1968); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving gablofen 2000 mcg/ml at 420.1 mcg/day vi an implantable pump.The patient¿s medical history included incomplete quadriplegia (c1-4), cervical disc disorder at c5-6 with myelopathy, intractable spasticity.The other medications the patient was taking at the time of the event was percocet, atenolol, loperamide, clonazepam, colace, cymbalta, gabapentin, furosemide, metformin, acetaminophen, fluticasone, cranberry extract, baclofen.It was reported that the physician had recently been increasing the patient¿s baclofen pump but the patient has reported diminishing benefit therapy.Per the clinic notes on (b)(6) 2022 the physician had increased the patient¿s dosage by 23% last friday which did not help decrease their spasticity.The patient works with a physical therapy who feels the patient was having difficulty with stamina and fatigues quickly and fighting against the spasms.The spasms were taking a lot of the patient¿s energy.The physician would give the patient another increase today and would currently receive 450 mcg/day.The home care nurse who fills the pump at home notified the physician that the last refill in january the pump was flipped which was new.The patient can feel the pump shifting when they sit or change positions.The concern was that the catheter was kinked or the motor was not adequately working.The physician contacted the company representative to discuss the case.There were no identified environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting performed was a trial bolus delivered, patient responded as expected with a decrease in spasticity.Rotor/dye study planned.The patient was referred for rotor/dye study.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 23-apr-2021, udi#: (b)(4).Product id: 8780, serial/lot #: (b)(4), ubd: 19-apr-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 company representative (rep) indicated the patient had a ¿failed catheter study¿ and the message was relayed to the doctor.The patient would be sent for a catheter revision (date not reported).

Manufacturer Narrative

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 reported that the cause for the failed dye study was the physician was unable to aspirate the catheter.

Manufacturer Narrative

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 reported the patient was taken to operating room to revise pump and/or catheter.Upon dissection to pump pocket, a spotty white substance was observed on all sides of pump.The catheter was noted to be twisted several times over, consistent with a flipping pump.Adjacent to the catheter connector, the catheter is sharply and acutely angled on both sides.The pump was disconnected and taken to the back table.The pump was programmed to deliver a bolus so that we could observe fluid exiting the pump to confirm its ability to dispense.Fluid was not observed during programmed bolus.The determination was made to revise the proximal catheter and to replace the pump given this patient's reliance on intrathecal baclofen.It should be noted that this patient was refilled by home care infusion using compounded baclofen.

Manufacturer Narrative

H3: analysis of the pump revealed no anomaly.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: 13630720
• MDR Text Key: 286340717
• Report Number: 3004209178-2022-02618
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2020
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 121 KG