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

Model Number 8637-40

Device Problems Improper or Incorrect Procedure or Method (2017); Connection Problem (2900); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-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 a healthcare provider (hcp) via company representative (rep) regarding a patient receiving morphine (unknown dosage/unknown concentration)/ bupivacaine (unknown dosage/unknown concentration) via an implantable pump.It was reported that the patient was complaining of headaches and this could be related to a spinal headache from the fractured catheter.Cather die study was performed.The patient came in for a catheter die study due to replacement of his pump it was noted that the catheter was unable to be aspirated at this time.In surgery it was noted that the catheter appeared fractured.The spinal segment was tired off in a new spinal segment was placed.Upon placing the needle of the 8598a the needle would not luer lock onto the low resistance (lor) syringe multiple lor syringes attempted a new 8598a kit was opened for a needle, and this needle worked with low resistance (lor) syringe.A new spinal segment and pump segment implanted and connected to a new pump and the therapy restarted for this patient.The patient status at the time of this report was alive with no injury.The medical history was back pain and spinal headache the environmental/external/patient factors were not reported.¿the 8598a kit was replaced with a new 8598a kit.The issue was resolved at the time of report.¿.

Event Description

Additional information was received that the needle lock was faulty, it did not lock on to the lor syringe.

Manufacturer Narrative

H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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) via company representative (rep) regarding a patient receiving morphine (unknown dosage/unknown concentration)/ bupivacaine (unknown dosage/unknown concentration) via an implantable pump.It was reported that the patient was complaining of headaches and this could be related to a spinal headache from the fractured catheter.Cather die study was performed.The patient came in for a catheter die study due to replacement of his pump it was noted that the catheter was unable to be aspirated at this time.In surgery it was noted that the catheter appeared fractured.The spinal segment was tired off in a new spinal segment was placed.Upon placing the needle of the 8598a the needle would not luer lock onto the low resistance (lor) syringe multiple lor syringes attempted a new 8598a kit was opened for a needle, and this needle worked with low resistance (lor) syringe.A new spinal segment and pump segment implanted and connected to a new pump and the therapy restarted for this patient.The patient status at the time of this report was alive with no injury.The medical history was back pain and spinal headache the environmental/external/patient factors were not reported.¿the 8598a kit was replaced with a new 8598a kit.The issue was resolved at the time of report.¿ (b)(6)2022 e1 (rep) additional information was received that the needle lock was faulty, it did not lock on to the lor syringe.(b)(6)2022 rp (rep) document contained no new information.(b)(6)2022 e2 (rep) document contained no new information.(b)(6)2022 ip (rep) document contained no new information.

Manufacturer Narrative

Product analysis #(b)(4) analysis information -- 2022-09-26 13:45:14 cst pli# 20 product id# 8637-40 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Destructive analysis identified residue in the motor gear train.Analysis identified wearing on the [upper/lower] shaft of gear number [one/two] (or the rotor).Medtronic developed a design change to reduce motor shaft wear and received regulatory approval for the change.Medtronic began distributing pumps with this design change in august 2017.Continuation of d10: product id 8731sc lot# serial# (b)(6) implanted: (b)(6)2010 explanted:(b)(6) 2022 product type catheter product id 8598a lot# serial# unknown implanted: explanted: product type catheter corrected rfr code for catheter and the kit.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

H3: analysis of the catheter (8731sc) found a hole caused by deep abrasion in the catheter body.Analysis of the catheter (8598a) found the introducer needle had damage and foreign material from customer usage.Analysis of the pump found wearing on the [upper/lower] shaft of gear number [one/two] (or the rotor).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

2022-08-09 mpxr 974625 (hcp, rep): information was received from a healthcare provider (hcp) via company representative (rep) regarding a patient receiving morphine (unknown dosage/unknown concentration)/ bupivacaine (unknown dosage/unknown concentration) via an implantable pump.It was reported that the patient was complaining of headaches and this could be related to a spinal headache from the fractured catheter.Cather die study was performed.The patient came in for a catheter die study due to replacement of his pump it was noted that the catheter was unable to be aspirated at this time.In surgery it was noted that the catheter appeared fractured.The spinal segment was tired off in a new spinal segment was placed.Upon placing the needle of the 8598a the needle would not luer lock onto the low resistance (lor) syringe multiple lor syringes attempted a new 8598a kit was opened for a needle, and this needle worked with low resistance (lor) syringe.A new spinal segment and pump segment implanted and connected to a new pump and the therapy restarted for this patient.The patient status at the time of this report was alive with no injury.The medical history was back pain and spinal headache the environmental/external/patient factors were not reported.¿the 8598a kit was replaced with a new 8598a kit.The issue was resolved at the time of report.¿.

• 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: 15245741
• MDR Text Key: 298113674
• Report Number: 3004209178-2022-10481
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 11/23/2022

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: 03/14/2018
• 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
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/09/2022; 09/28/2022; 11/07/2022
• Supplement Dates FDA Received: 09/12/2022; 10/03/2022; 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2016
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 107 KG