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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

Patient Problems Fatigue (1849); Nausea (1970); Overdose (1988); Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359); Sleep Dysfunction (2517)

Event Date 10/10/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine 20 mg/ml at 8.2 mg/day via an implantable pump.It was reported that a motor stall occurred on (b)(6) 2020 with an alarm.The patient experienced withdrawal symptoms (inner unrest, severe pain (vas 8) in arms and legs, insomnia, nausea, flu-like symptoms), but sometimes patient showed overdosing symptoms (drowsiness).Diagnostics/troubleshooting included interrogation and an acoustic alarm.¿log files were not available since the physician decided to replace the pump anyway¿.The pump would be replaced; until then, oral substitution [was administered], and the hcp was advised to program to minimum rate or temporary stop.Replacement was planned but had not yet been scheduled.The issue was not resolved.The patient's status was alive, with injury.It was noted that the pump was implanted in (b)(6) 2014 (no further specific date provided).The hcp confirmed that at least for the last few years, no drug was used other than morphine.In the past, the daily dose was reduced for a certain time compared to current dose (with no complaint).Information regarding the patient¿s gender, age, weight, medical history, and other medications was unavailable.

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

There were no environmental, external or patient factors (mri or similar) that might have led or contributed to the event.

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 received on 2020-oct-26 indicated that further examinations revealed that the patient had a heart attack too (it was indicated that the time of the heart attack was unknown but there was no allegation of a suspected relationship to the pump/event).It was noted that because anesthesia is contraindicated for 6 months, explant could not be done right now.The pump was filled with saline solution and stopped.

• 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: 10671255
• MDR Text Key: 215021094
• Report Number: 3004209178-2020-17832
• Device Sequence Number: 1
• Product Code: LKK
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention