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

Model Number 8637-40

Device Problems Disconnection (1171); Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problems Overdose (1988); Seizures, Grand-Mal (2168); Complaint, Ill-Defined (2331); Irritability (2421)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 26-feb-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving an unknown medication via an implanted pump.It was reported that the patient exhibited extreme agitation after the routine refill on (b)(6) 2020.The patient was taken to the hospital and given narcan with no response.An x-ray showed that the catheter had become dislodged from the pump stem in the pump pocket.The patient stated that he would rather have the pump removed than have surgery to repair it.The whole system was removed the next day(b)(6) 2020.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The issue was reported to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.The patient status was reported as ¿alive ¿ no injury¿.No further complications were reported/anticipated.

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.Analysis of the catheter revealed catheter body torn or broken or melted at or after explant; did not affect infusion.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

Concomitant medical product: product id 8781 lot# serial#(b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2020 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

Additional information was received from the consumer and the manufacturing representative (rep).The patient reported that since (b)(6).Their catheter "disintegrated." the patient reported they were refilled on (b)(6) 2020.(previously noted as (b)(6).), and during the refill, they noticed that they could "see my stomach swelling up bigger and bigger where the pump was at.It was burning my stomach really bad and i told the doctor and finally looked at it and he called 911 and they came and by then i was having grand mal seizures, so they rushed me to the hospital and had to resuscitate me twice and i was in the icu (intensive care unit) for three days, and they said the bupivacaine would mess with my heart and cause seizures." the patient stated they took the pump out "because the catheter had disintegrated, and parts of it are still implanted in my body." the patient stated they were upset because they almost died.The patient was taking oral medications currently, at the time of the report (b)(6) 2020.The rep reported they were in possession of the explanted pump and catheter and planned to return them to the manufacturer.It was indicated the device had been dispensing an unknown dose and concentration of bupivacaine and fentanyl.

• 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
• MDR Report Key: 10016929
• MDR Text Key: 189578477
• Report Number: 3004209178-2020-07968
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

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: 10/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 05/01/2020; 06/17/2020
• Supplement Dates FDA Received: 05/27/2020; 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR