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

Model Number 8637-20

Device Problems Disconnection (1171); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Incontinence (1928); Oversedation (1990); Weakness (2145); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 11/01/2018

Event Type  malfunction  

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 who was receiving bupivacaine and dilaudid via an implantable pump for non-malignant pain.The drug concentrations and dose rates of the pump medications were unknown.It was reported the pump has been broken for years and the doctors are just now catching up.The date of event was unknown.The patient wanted a second opinion from a doctor about his pump.At the time of the report it was indicated that "you should know what the medication is doing to me".This comment was not otherwise further clarified at the time of the report.Physician listings were provided.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780 serial/lot# n532380003, ubd 2017-03-27, udi# (b)(4) 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.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 healthcare professional (hcp) who reported that the issue was first noticed in (b)(6) of 2018.The patient had lack of efficacy, incontinence, excessive sedation, decreased ability for smell/taste, and weakness.On (b)(6) 2019 there was an order for an mri of the lumbar spine and thoracic/lumbar x-rays which showed the catheter tip at t8.A catheter dye study was done on (b)(6) 2019 and there was no difficulty aspirating back and it was recommended pulling down the catheter 2-4 segments.Another dye study was done on (b)(6) 2019 and there was difficulty aspirating back.The cause of the issue was undetermined.The patient reported that he had a ct scan of his abdomen for a different health concern and it was noted that the pump was disconnected.Their office had not seen the report for this scan.Pump replacement was recommended and a dye study during the operation to determine the integrity of the catheter.This issue was not yet resolved.The patient¿s devices remained in use and the patient was waiting for a pump replacement and possible catheter revision until after the coronavirus pandemic per the patient¿s request.

• 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: 10663420
• MDR Text Key: 211675002
• Report Number: 3004209178-2020-17742
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR