MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Protective Measures Problem (3015)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot# unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, 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 provider (hcp) via social media ((b)(6)) regarding a patient who was receiving morphine (unknown concentration and dose) via an implantable pump for abdominal pain from advanced pancreatic cancer.It was reported there was excellent pain control with the spinal infusion pump (synchromed ii) during the first 6 months.The patient was under chemotherapy treatment.Afterwards, the patient started complaining of a progressive increase of their habitual pain, despite increasing morphine daily dose and adding bupivacaine.The patient needed repeated high daily doses of short acting fentanyl.During the next pump refill, continuous fluoroscopy was done to check the catheter.The hcp couldn't confirm it, because only the tip of the catheter was radiopaque and it was difficult to see.Finally, a ct scan was made and informed by a radiologist, describing the stability of the tumor and the misplacement of the catheter.The catheter was placed in a subcutaneous plane, so the hcp went again to surgery.Further complications were not reported.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2019, 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

Additional information was received.It was reported the catheter migrated out of the intrathecal space.The catheter was replaced on (b)(6) 2019 and the event resolved.No contributing factors to the event were identified.The catheter would not be returned, because the customer considered there was not a problem with the catheter, only a migration.Additional information was received.The patient's pump and catheter were implanted on (b)(6) 2018.The date the patient began to experience the increase in pain was not obtained.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8612205
• MDR Text Key: 145125479
• Report Number: 3007566237-2019-01072
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention