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

Model Number 8637-40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Cyanosis (1798); Death (1802); Dyspnea (1816); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Incontinence (1928); Overdose (1988); Swelling (2091); Ventricular Fibrillation (2130); Dizziness (2194); Complaint, Ill-Defined (2331)

Event Date 06/24/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving dilaudid at an unknown concentration and dose via an implantable infusion pump.It was reported that the patient passed away on (b)(6) 2019 while having his pump refilled.Initially the patient was going to have the pump filled on the (b)(6), but they couldn't find the refill port, so the refill was rescheduled for the (b)(6) at the surgery center so they could x-ray the port location.The caller stated that the medication was injected into the patient's body instead of the pump and it "killed the patient by overdose." they noted that the pump "was working perfectly before [the patient] went in to have his pump filled." additional information received from the office manager of the clinic indicated that the refill was performed on (b)(6) 2019 without difficulty while under x-ray, then the patient experienced breathing difficulties in recovery and was taken to the hospital.They experienced cardiopulmonary arrest while at the hospital and expired on (b)(6) 2019.The cause of death was not known by the caller or recorded in the notes available to them.Additional information was requested from the medical records department of the hospital, but was not provided.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer reported on or about (b)(6) 2019, the patient presented to the clinic for a routine refill of the intrathecal pump.During the administration of the pain medication, the patient began to feel lightheaded and their oxygen saturation began to decrease.The patient then turned more cyanotic and drowsy, and a decision was made to start assisting the patient's respiration with bag/mask technique.Nevertheless, the patient became unresponsive and a code was ~called.The patient was transferred emergently to (b)(6) emergency department where they were pronounced deceased from cardiac arrest.

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 a health care professional (hcp) on 2020-may-15.It was reported that the patient had his pump refilled under fluoroscopy on (b)(6) 2019 where according to patient records he was stable, alert, and oriented afterwards.However he then became unresponsive at the surgery center.He experienced shortness of breath and respiratory distress.Compressions were started by the nursing staff and normal saline, naloxone, a total of 2 mg epi 1: 10 ,000, and 50 meq sodium bicarbonate was given via iv.He was in ventricular fibrillation, agonal respirations were noted and the patient's skin was purple from the neck to the head.He was given three doses of epinephrine and he was defibrillated 6 times prior to arrival in the emergency room (er).Swelling was noted at the iv site on the patient's hand, so the iv was removed and established elsewhere.On arrival at the er, no cardiac tissue movement was noted on ultrasound.Oxygen saturations remained 80-83% during compressions.Lifesaving measures were continued with no change in patient status.The patient was pronounced dead on arrival at the er at 16:28 on (b)(6) 2019.The patient's final diagnoses in the er were cardiac arrest; cause unspecified, shortness of breath, cyanosis, abdominal distension (gaseous), and unspecified urinary incontinence.No further complications were reported.

Event Description

Additional information received from a consumer reported the patient passed away due to sudden cardiac death and atherosclerotic and hypertensive heart disease.It was noted the hypertension and pain pump refill procedure were contributing factors.

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.

• 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: 10052574
• MDR Text Key: 190812879
• Report Number: 3004209178-2020-08532
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 70 YR