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

Model Number 8637-40

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8870, serial#: (b)(4), product type: software.Other relevant device(s) are: product id: 8870, serial/lot #: (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 clinical study and a manufacturer representative (rep) regarding a patient receiving remodulin 10 mg/ml for a total dose of 4.722 mg/day via an implantable pump.It was reported there were unexpected low and empty reservoir alarms in the logs.On (b)(6) 2020, the patient underwent a pump refill and the alarm check was completed post refill.Roughly 10 minutes after this, they heard an alarm go off.The pump was interrogated again, and all looked normal on the interrogation.Per the site, the interrogation post refill included an empty reservoir alarm occurred and a low reservoir alarm occurred both on (b)(6) 2020 at 13:45.The pump status reports were reviewed and found no reason for the critical alarm sounding after the refill on (b)(6) 2020.It was noted that a software bug was suspected as there were 8 similar events.The event will try to be replicated given the programming details.No symptoms were reported.No actions or interventions were taken.The event date was (b)(6) 2020.No further complications were reported/anticipated.(b)(6) 2020 e2 (hcp, sdy, rep): additional information was received from an hcp via a clinical study and manufacturer representative on (b)(6) 2020.It was reported that logs were checked to confirm that the reservoir volume was updated after refill.40ml were filled into the reservoir and the cause of the issue was believed to be a software bug.The issue was explained and resolved.

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 via a clinical study and manufacturer representative on (b)(6) 2020.It was reported that the patient's medical history included non-specific chest pain, dyspnea, fatigue/weakness, hypertension, pulmonary hypertension (ph), irregular heart beat, prostanoid induced diarrhea, poor appetite, lactose intolerance, untreated sleep apnea, marijuana use, a corpus luteum cyst with hemorrhage, pelvic inflammatory disease (pid), pelvic pain, tubal ligation, vitamin k allergy, endometrial ablasion, sciatica, migraines, pg12 headache/flushing/leg pain, menorrhagia, urinary tract infection (uti), ovarian cysts, hip pain, transcranial magnetic stimulation (tms), and dyspareunia.No assessment was made for product/therapy/procedure relatedness by the investigator, sponsor, or clinical endpoint committee (cec).No additional medical intervention was required to prevent permanent injury or impairment.

• 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: 10368091
• MDR Text Key: 201907810
• Report Number: 3004209178-2020-13481
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• Combination Product (y/n): N
• PMA/PMN Number: P140032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Weight: 50