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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving dilaudid (unknown dose and concentration), bupivacaine (unknown dose and concentration), and clonidine (unknown dose and concentration) via an implantable infusion pump.The indication for use was non-malignant pain it was reported that the patient heard the pump alarm and experienced withdrawal symptoms.The logs could not be pulled to check the stall date.The patient was scheduled for pump replacement on (b)(6) 2022.Additional information was received from a healthcare provider (hcp) via a company representative (rep) on 2022-may-07 indicated the patient was receiving dilaudid (15 g/ml at 4.373 mg/day), bupivacaine (5mg/ml at 1.4578 mg/day), and clonidine (150 mcg/ml at 43.73 mcg/day) via an implantable infusion pump.It was reported that the patient ¿s pump was interrogated and found a motor stall.The patient thought he may have noticed an alarm ¿maybe two weeks ago¿, but stated he wasn¿t sure.His wife stated he started feeling bad ¿a few days ago.¿ after at least two additional pump interrogations following 20min wait time, the motor stall did not recover.The patient went through withdrawal and underdose, and was given oral medication to assist with withdrawal symptoms.The patient¿s pump was nearing the end of life therefore he was scheduled for pump replacement on 2022-05-11.The patient denied being near sources of electromagnetic interference (emi), magnets or any falls/accidents.The patient¿s status at the time of the event was ¿alive ¿ with injury¿.The patient¿s weight and medical history were asked but were unknown.Additional information was received again from a hcp via a rep on 2022-may-09 that stated the logs showed the pump stalled at 2am on 2022-05-06 with no recovery.The patient planned to replace the pump on 2022-05-11 however, wanted to know if the motor stall would affect the catheter.Technical services reviewed motor stall should not have caused an issue with the catheter.Technical services reviewed to check catheter patency as normal during pump replacement.It was noted the hcp did not want to aspirate the catheter per medical decision.Additional information was received from a rep who reported that the pump was replaced.Additional information was received from the hcp via a rep on 2022-may-12 indicated the cause of the alarm two weeks prior was unknown.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

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.

Manufacturer Narrative

H3: analysis of the pump revealed pump motor gear train anomaly; corrosion and or wear and or lubrication; stall due to shaft bearing; pump motor; o-ring wear.H6: corrected information: device code a26 not applicable 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: 14431394
• MDR Text Key: 291972875
• Report Number: 3004209178-2022-06331
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male