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

Model Number 8637-40

Device Problems Device Markings/Labelling Problem (2911); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 8731sc lot# serial# (b)(4) implanted: (b)(6) 2011 explanted: product type catheter product id 8731sc lot# serial# (b)(4) implanted: (b)(6) 2011 explanted: product type catheter product id a810 lot# serial# unknown implanted: explanted: product type software section d information references the main component of the system.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 04-aug-2011, 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

Information was received from the healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system.The pump was used to deliver dilaudid 30mg/ml at 18mg/day and bupivacaine 1mg/ml at an unknown dose.It was reported that, during a pump replacement, the surgeon could not access the full catheter.Upon interrogating the patient's old pump note from 2018, it was noted that the patient was registered with a 8731 catheter.However, at the time of interrogation, the catheter from 2018 was noted to be a 8711 catheter.They kept the catheter at the last reading.No changes to the catheter had been made at that time and no changes were made at the time of the current replacement.Due not being able to verify the exact catheter, the reporter did not want to prime the entire system, so a back table prime was completed.There were no ill effects experienced by the patient.At the time of this report, the catheter remained active.Environmental, external, or patientfactors that may have led or contributed to the issue were not applicable.The exact catheter length, model, or volume was not able to be confirmed.At the time of this report, the issue was not resolved and the patient status was "alive-no injury.As of (b)(6) 2023, the programming error had not resolved.It was noted that the physician had used the samsung handset with an unknown software version.The patient's weight was asked but was unknown.

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 healthcare provider via a company representative stating.The healthcare provider stated previously that the catheter was replaced but the company representative stated that the catheter was not replaced at the most recent surgery.

Manufacturer Narrative

Continuation of d10: product id 8731sc lot# serial# (b)(6) implanted: (b)(6)2011 product type catheter product id 8731sc lot# serial# (b)(6) implanted: (b)(6)2011 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

Information was received from a healthcare provider (hcp) regarding a patient receiving unknown medication via implanted infusion pump.It was reported that the patient's pump needed to be replaced.There was no documentation of the length of the intrathecal catheter to prime the drug dose to fill the catheter.The catheter that was implanted into the patient did not have printed numbers to determine the length of the catheter.No further information was provided.Additional information was received from a healthcare provider (hcp) on (b)(6)2023 who reported patient information and pump serial number.The hcp reported that the patient's pump was explanted due to normal battery depletion.The catheter was also replaced.The explant date of the pump was reported to be (b)(6)2023 although previously reported (b)(6)2023.The patient's weight was provided.

• 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: 16832751
• MDR Text Key: 314189313
• Report Number: 3004209178-2023-05675
• 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
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Date Device Manufactured: 09/12/2018
• 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: 70 KG