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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Malaise (2359); Cognitive Changes (2551)

Event Date 09/15/2019

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 healthcare provider (hcp) on 2019-sep-25 regarding a patient receiving hydromorphone, bupivacaine, and prialt (doses and concentrations unknown) via an implanted infusion pump.The indication for use was non-malignant pain.It was reported that the patient had a refill on (b)(6) 2019 and the dose was increased on the hydromorphone and prialt.On approximately (b)(6) 2019 the patient started having flu like symptoms, and on (b)(6) 2019 the patient was hallucinating.The patient also had labored breathing while awake and asleep.It was noted that it was normal for the patient to have labored breathing while sleeping, but unusual for the patient while awake.The onset of symptoms was considered sudden.On (b)(6) 2019 the patient's husband found them unresponsive and dead at home.Life saving measures were not initiated due to obvious signs of death.It was indicated that the cause of death was unknown, but it was thought that the death was related to the device/therapy.An autopsy was being completed and a manufacturer representative was requested to interrogate the pump.It was noted that the pump would be explanted.No further complications were reported or anticipated.

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 an hcp on 2020-jan-03.It was reported that per the autopsy report, the cause of death was hypertensive cardiovascular disease.Other significant conditions that may have led or contributed to the death included morbid obesity, and the manner of death was considered natural.It was noted that postmortem pain pump interrogation was consistent with correct delivery of the programmed medication dosages of hydromorphone, bupivacaine, and ziconotide.

• 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: 9232813
• MDR Text Key: 163570709
• Report Number: 3004209178-2019-20307
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 48 YR