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

Model Number 8637-20

Device Problems Infusion or Flow Problem (2964); Protective Measures Problem (3015)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/08/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving dilaudid (30 mg/ml, 4.5 mg/day), bupivacaine (20 mg/ml, 3 mg/day) fentanyl (100 mcg/ml, 150 mcg/day) and clonidine (100 mcg/ml, 15 mcg/day) via an implantable pump.It was reported the patient was new to the hcp.The patient presented for a normal pump refill procedure, but the hcp decided to also perform a catheter dye study because of the contents of the pump and the patient had complained of still having pain.The expected reservoir volume (erv) was 3.6 ml and the actual reservoir volume (arv) was 3.0 ml.The pump was then filled with 20 ml of sufentanil (50 mcg/ml).The catheter access port (cap) was then accessed.The hcp easily drew back 3 ml of fluid, injected contrast and used x-ray to visualize the catheter.They were unable to visualize the catheter.They were able to see the tip of the catheter, but there was no dye exiting the top of the catheter.The hcp injected a second time and still no dye was moving to make the catheter visible.The hcp decided to place the pump on minimum rate at 0.297 mcg/day (0.012 mcg/hr).The patient was scheduled for revision.They would supplement with oral medication until revision surgery on (b)(6) 2022.The issue was not resolved at the time of this report.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6)2013, product type :catheter, ubd: 28-feb-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative (rep) indicated the catheter revision surgery was completed on (b)(6) 2022.The existing pump remained in use.The pump contained sufentanil 50mcg/ml concentration infusing at 2.4mcg/day.It was noted on (b)(6) 2022, the rep spoke with the managing physician, and he stated the patient was now doing very well.

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14106260
• MDR Text Key: 289223328
• Report Number: 3004209178-2022-04700
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/25/2022
• Date Device Manufactured: 01/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female