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

Model Number 8637-20

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Device Ingredient or Reagent Problem (2910)

Patient Problems Fluid Discharge (2686); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Information was received from the healthcare provider (hcp) regarding the patient receiving morphine (dosage/concentration was not available).The indication for use was for non-malignant pain.It was reported that the company representative was doing refill with the patient.The healthcare provider (hcp) stated physician was able to get 10cc's out of pump (expected) with some resistance but experiencing a lot of resistance trying put new drug in the pump.The technical services (tss) confirmed patient was a difficult stick, turning the needle and discussed possible air in reservoir.The hcp had physician apply negative pressure multiple times until air bubbles stopped.Physician still experiencing resistance, so the tss advised trying new refill kit.The hcp suspected pocket fill.The hcp stated that they are concerned about potential baclofen overdose as pump was refilled earlier today and they suspect a pocket fill occurred.The hcp stated that there was fluid "bubbling in subcutaneous tissue." the hcp noted that a needle was used to remove some of the fluid, but they believe there to be about 11 ml of baclofen in the subcutaneous space.The issue was not resolved through troubleshooting.

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.

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 the company representative the patients weight at the time of the report was unknown.The cause of the difficulty aspirating was assumed air in the reservoir that caused difficulty injecting.The needle came out of the reservoir assumed cause of pocket fill.The cause of the potential baclofen overdose was medication injected in the pocket.As an intervention the air was aspirated out of the reservoir.As an action/intervention some baclofen was withdrawn from the pocket.The patient went to the hospital to monitor for overdose symptoms.The potential baclofen overdose/swelling in the pocket resolved.The patient was doing well on oral baclofen.The plan was to refill again on (b)(6) 2023.The difficulty injecting or aspirating resolved.

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 the healthcare provider.It was reported that there was a suspected pocket fill.The healthcare provider stated that they are concerned about potential baclofen overdose as pump was refilled on (b)(6) 2023 and they suspect a pocket fill occurred.The healthcare provider stated that there was fluid "bubbling in subcutaneous tissue." the healthcare provider noted that a needle was used to remove some of the fluid but they believe there to be about 11 ml of baclofen in the subcutaneous space.The issue was not resolved through troubleshooting.The technical services sent baclofen emergency procedures document.Additional information was received from the company representative.It was reported that the pump pocket was swollen and oozing fluid.The company representative stated they put 17 ccs of drug in.The technical services (tss) advised removing drug from reservoir.The company representative stated 6ccs of blood-tinged fluid were removed from reservoir.The company representative stated patient involuntarily moving and coughing making it likely that the needle moved during refill.The tss discussed possibility for overdose and subsequent under dose and advised physician to speak to a pharmacist for pharmacological information.The company stated the patient daughter reported potential overdose and pocket fill.

• 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: 16314603
• MDR Text Key: 308970654
• Report Number: 3004209178-2023-01740
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Report Date: 02/22/2023

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: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/08/2023; 02/21/2023
• Supplement Dates FDA Received: 02/13/2023; 02/22/2023
• Date Device Manufactured: 07/17/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male