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

Model Number 8637-20

Device Problems Device Ingredient or Reagent Problem (2910); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Muscular Rigidity (1968); Loss of consciousness (2418)

Event Date 02/06/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-may-2021, udi#: (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 manufacturer representative (rep) regarding a patient receiving an unknown baclofen (unknown dose and concentration) via an implantable pump.It was reported the hcp call the rep to discuss the patient who was admitted to the hospital on (b)(6) 2021 for an unrelated issue.The patient was due for a refill on that day ((b)(6) 2021), but was not due to be alarming until (b)(6) 2021.It was noted that sometime after being admitted the patient started having increase creatine levels and hypotension.On (b)(6) 2021 the hcp was called to assess the pump for malfunction.No issue was found at that time.On (b)(6) 2021 the hcp was notified that the patient was unresponsive and had to be intubated.This is when the hcp called the rep.They discussed the patient's symptoms which included hypotension, increased creatinine and unresponsiveness but not increased spasticity.They discussed checking the reservoir volume to assure the reservoir did not empty prematurely and were doing a dye study.It was noted they would supplement the patient orally or intravenously. the reservoir volume was accurate; however, the dye study revealed an issue with the catheter.They were unable to aspirate through the catheter access port (cap), but returned a cloudy substance that was sent for culture.A subsequent computed tomography (ct) scan relieved a broken catheter.A catheter revision is expected once the patient is stable enough for surgery.The patient was currently being supplemented with oral baclofen as well as antibiotics.It was noted the issue was note resolved.The event date was (b)(6) 2021.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(6), implanted: (b)(6) 2019, explanted: product type catheter 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

Information was received from the healthcare provider via a device manufacturer representative indicated that the cause of the cloudy fluid was likely from the sacral wound and the fractured catheter close by.

• 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: 11339115
• MDR Text Key: 238445633
• Report Number: 3004209178-2021-02770
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR