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 Dyspnea (1816); Muscular Rigidity (1968); Scar Tissue (2060); Scarring (2061); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

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, dose and concentration not reported via an implantable pump.The indications for use was intractable spasticity and spinal cord injury/spinal cord disease.On (b)(6) 2019 the patient reported she has had an increase in spasticity and was from the breasts down and feels tight.The patient stated sometimes it is hard to take a breathe, sometimes she cannot move, cannot get in and out of cars and sometimes she cannot bend her legs.Per the patient it has progressively gotten worse and worse like she is having signs of withdrawal.The patient had a dye study done and everything seemed normal and was wondering if pump is stopping and starting on its own.The patient thinks something is wrong with their pump and had an appointment with the healthcare provider on friday and wanted a company representative to be present.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient had a lot of problems with her current pump (implanted (b)(6) 2017) she had issues "pretty much" since she got her pump.She could not breathe sometimes because the spasticity went up to her chest and then it would come down.The healthcare provider (hcp) knew there was something wrong with the pump but could not "prove it." the patient did not have someone to change the pump out but she knew something was wrong.The pump was not alarming.She had withdrawal symptoms where she went from no drug then in hours all of sudden she would be loose but then that did not last and her spasticity would come back.She charted her symptoms and could tell that she got drug at some times and then no drug at others.The bolus would go through but the hcp was concerned "if the pump gives less medication then the catheter fills up then drug goes through." the patient had a program where the hcp has his own bolus shots every couple of hours.Another hcp she saw said the symptoms the patient had were symptoms that could be related to withdrawal and the patient was worried about not getting enough medication; she knew she had withdrawal with this pump.The patient had called a pharmacist to see if it was possible for the patient to develop a tolerance to baclofen because she had pumps for years but the pharmacist said the patient would not be able to develop a tolerance.The patient's quality of life was going downhill.A dye study did not show anything wrong and the catheter was fine as far as they could tell.The patient had an appointment to see another hcp to check her pump and was trying to see a surgeon within the next week or so (relative to (b)(6) 2019).She had never had issues until she got the synchromed ii pump model.There were no further complications reported at this time.

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 on 06-may-2019 from the patient who reported that her hcp (healthcare professional) still did not think that the pump was working, so had scheduled a baclofen trial like a pre-pump trial to see if the patient responded to the baclofen.It was initially scheduled for this thursday ((b)(6) 2019) but was cancelled/delayed because the hcp requested a head ct for her.She had already had a head ct at the end of the year and she was wondering if requesting a head ct was normal.No further complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8780 serial/lot# (b)(4), ubd 2017-05-14, udi# (b)(4).Other relevant device(s) are: product id: 8780 serial/lot# (b)(4), ubd 2019-02-16, udi# (b)(4).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 on 05-june-2019 from the patient who again reported that the pump had not been working since she had it replaced a few years ago and since then her spasticity had been a nightmare.Per the patient, they didn¿t want to just replace the pump as they didn¿t know why it wouldn¿t be working.They wantedto do an mri and they didn¿t know how that would work because she had a stimulation device.They think the catheter may not be working correctly, but they are not sure.Per the patient, she was ¿becoming paralyzed due to the spasticity¿.She wanted to know if the pump logs would show stalls.The patient stated that she had had issues since her previous pump, but that was likely due to scarring.The patient didn¿t know if ¿the lead was moved due to scarring during the previous refill¿.The patient asked about recalls.No further complications have been reported as a result of this event.

Manufacturer Narrative

H6: c34483 no longer applies.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: 8482969
• MDR Text Key: 140915343
• Report Number: 3004209178-2019-06699
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR