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); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 11/30/2021

Event Type  Injury  

Event Description

Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient who was receiving bupivacaine (10 mg/ml at 3.732 mg/day) and morphine (unknown) (20 mg/ml at 7.463 mg/day) via an implantable pump for spinal pain.It was reported that patient was having trouble getting their ptm to connect to their pump.The patient stated that on (b)(6) 2022, they woke up at 4-something in morning and it took an hour and 45 minutes to get a bolus.The patient stated that they would press their myptm and the screen would go blank.The patient stated that "i'm in a lot of pain", "i hurt so bad", "morphine isn't working", and they hurt from "the top of my head to the bottom of my toes".Patient services reviewed with the patient the best positioning for the communicator over the pump when using the ptm and the patent was able to get their ptm to connect to the pump but was currently in a lockout.Additional information received from a consumer (con) via company representative (rep) reported that the patient's ptm was "giving them some problems" and not giving them a bolus instantly.Additional information received from the company representative (rep) reported that the physician stated they will be doing a pump revision at a later date as they thought that the pump being flipped could be causing the patient's ptm issue or causing them to not get their bolus.Of note, the patient has been having the same issues intermittently.Additional information received from a consumer (con) reported that on (b)(6) 2022, either at 6 am or 8 am, the patient stated feeling short of breath and in a lot of pain.The patient stated that they should have a bolus every 2 hours; however, she was locked out.Additionally, the patient stated that they have a message on their ptm prompting them to create a password using a code on the screen.The patient confirmed that the equipment was working as intended.The patient mentioned that they are "in a lot of pain" and stated "i've never been in this much pain since i've had the pump".Of note, the patient additionally noted also receiving baclofen (100 mcg/ml at 78.92 mcg/day) and dilaudid (40 mg/ml at 3.1567 mg/day).

Manufacturer Narrative

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

Event Description

Additional information was received from the device manufacturer representative indicated that surgery was scheduled for (b)(6) 2022.

Manufacturer Narrative

Continuation of d10: product id tm90t0 lot# serial# unknown product type accessory product id a820 product type software 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 the company representative (rep) stated that revising the catheter resolved the problem.There was not in fact a problem with the ptm.

Manufacturer Narrative

Continuation of d10: product id: 8780, serial#: (b)(6), product type: catheter.Product id: tm90t0, serial#: unknown, product type: accessory.Product id: a820, product type: software.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: explanted: product type catheter product id tm90t0 lot# serial# unknown implanted: explanted: product type accessory product id a820 lot# serial# implanted: explanted: product type software.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

On 2022-mar-24, additional information was received from the manufacturer representative (rep).It was reported that the catheter was not removed when it was revised.There was nothing wrong with the catheter.The pump had been flipping due to not being anchored properly so the catheter was "coiled up like a spaghetti factory".The hcp was able to aspirate through the catheter access port (cap) so he did not think there was an issue with the catheter.The section of the catheter that was removed was discarded.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: explanted: product type catheter product id tm90t0 lot# serial# unknown implanted: explanted: product type accessory product id a820 lot# serial# implanted: explanted: product type software.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: 13515670
• MDR Text Key: 285625481
• Report Number: 3004209178-2022-01925
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• Date Device Manufactured: 05/24/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Female