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

Model Number 8637-20

Device Problems Filling Problem (1233); Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hypothermia (1915); Overdose (1988); Loss of consciousness (2418); Cognitive Changes (2551)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, lot #: unknown, explanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: unknown.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 who was receiving compounded baclofen at an unknown concentration and dose via an implantable pump.The indication for use was not provided.It was initially reported on (b)(6) 2019 that after the last refill in (b)(6), the patient had a baclofen overdose and was hospitalized.There was no volume discrepancy.The surgeon decided to check the pump and catheter on (b)(6) 2019 and when opening, they observed the catheter was disconnected from the pump.A part of the pump segment of the catheter was replaced and the pump was replaced.The patient seemed to feel better.At the time of the report the issue was resolved and the patient status was alive with no injury.It was indicated the pump would be returned.It was noted that the patient was first implanted about 15 years ago, with the most recent pump replacement being in (b)(6) 2018.A user report received included additional details that the refill visit was done in the morning on (b)(6) 2019.The patient returned home and it was difficult to wake them up at 4 pm.At the clinical exam, the patient was asleep with spontaneous breathing, no desaturation, and no eyes opening when slight stimulation was done.It was stated that there was a "doubt about a small collection in front of the pump, and no punction was performed." the patient was hospitalized in the intensive care unit (icu) and the pump was programmed to the minimum flow rate.A surgical revision was done on (b)(6) 2019 and the surgeon observed that the catheter was "broken" and that the pump was half empty whereas the previous refill was done on "(b)(6) 2019" [manufacturer representative assumed this date was a mistake because (b)(6) 2019 as this was the date of the refill reported at the beginning of the user report] (please note this information conflicts with the initial report to the manufacturer that the surgical intervention was done on (b)(6) 2019, that the catheter was "disconnected" [not "broken"] and that there was no volume discrepancy).Additional information received via follow-up indicated that the cause of the catheter disconnection from the pump was not determined.No programming changes or drug changes were made at the refill, according to the physician.It was indicated that it seemed the programmed parameters of the pump were confirmed to be correct and that it seemed the drug type and concentration used to fill the pump were confirmed to be correct.It was stated that the physician was informed to keep the catheter for return but it was finally discarded.It was confirmed that the surgical intervention took place on (b)(6) 2019.It was also noted that during the last two refills ((b)(6) 2018 and (b)(6) 2019) the reservoir septum was difficult to locate, per the physician.It was indicated that there was "nothing to declare" for contributing factors of the difficulty locating the septum, but was also stated that the manufacturer's refill kit was not used.It was clarified that there was fluid around the pump observed after the refill when the patient came back to the hospital at the end of the day, which was observed by a different physician than the one who did the refill in the morning.The fluid was not "punctioned." in addition, the pump was not emptied and no volume comparison was done at this stage, only the pump was programmed at the minimal rate.It was further detailed that after the previous refill on (b)(6) 2018 the patient presented problems of alertness associated with hypothermia and there was a collection of fluid around the pump."it was determined that the pump refill was done out of the pump." no further complications were reported or anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via follow-up.It was reported that the report that the catheter was broken was true.Imaging such as fluoroscopy or ultrasound was not used to confirm needle position during the refill on (b)(6) 2019.During the refill the drug was periodically withdrawn to confirm it had the expected appearance, and it was indicated that it did have the expected appearance.The needle used to refill the pump was a huber b braun needle size 22 gauge/25 mm.The compounded baclofen being delivered at the time of the event was 2000 mcg/ml at a dose of 244 mcg/day.

Manufacturer Narrative

The returned pump passed all testing in the laboratory and no anomalies were identified.Testing.Visual inspection of the returned catheter identified a break in the catheter body.Analysis of the catheter also identified a leak that was caused by the metal tip of the pump connector breaching the catheter.(b)(4).If information is provided in the future, a supplemental report will be issued.

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: 8433811
• MDR Text Key: 139239322
• Report Number: 3004209178-2019-05607
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1060-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention