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

Model Number 8637

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Purulent Discharge (1812); Headache (1880); Unspecified Infection (1930); Pneumothorax (2012); Sepsis (2067); Urinary Tract Infection (2120); Meningitis (2389); Post Operative Wound Infection (2446); Respiratory Failure (2484); Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2022

Event Type  Injury  

Event Description

Wilson c, linczer j, newman s, et al.Intrathecal baclofen and opioid therapy: cerebrospinal fluid leak and infection incidence, risk factors, and outcomes.World neurosurg.2022;doi:10.1016/j.Wneu.2022.12.039 summary: intrathecal drug therapy treats medically refractory spasticity and pain.Cerebrospinal fluid (csf) leak or infection can limit efficacy and increase morbidity.We aim to evaluate risk factors and outcomes after csf leaks and infections requiring reoperation.Reported events: it was reported pump explantations without replacement due to infection occurred.It was reported 12 patients had deep infections requiring reoperation.Reoperation for infection was completed in the setting of dehiscent wounds with exposed hardware, purulent drainage, or signs of sepsis and associated signs of surgical site infection.Complications included 5 overdoses.Complications included 5 respiratory failures.Complications included 1 withdrawal.Complications included 2 seizure.Complications included 1 atelectasis.Complications included 2 urinary tract infections.Complications included 1 abdominal compartment syndrome.It was reported 47 of 226 patients developed csf leaks requiring operative intervention.Patients were reoperated for csf leak if they had csf leakage through the incision, persistent positional headache refractory to recumbency, epidural blood patches and caffeine supplementation, persistent subcutaneous fluid collection, or poor clinical effect despite higher pump dosing.Complications included 3 meningitis.It was reported cases where a non-functional catheter was observed occurred.The catheters were replaced.It was reported 22 patients had superficial infections that resolved with antibiotics alone.

Manufacturer Narrative

Continuation of concomitant medical product: product id: 8637, lot# , serial# unknown, product type: pump.Product id: 8781, lot# unknown, product type: catheter.Product id: 8637, serial# unknown, product type: pump.Product id: 8637, lot#, serial# unknown, product type: pump.Other relevant device(s) are: product id: 8781, serial/lot #: unknown.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16422768
• MDR Text Key: 310047639
• Report Number: 2182207-2023-00335
• Device Sequence Number: 1
• Product Code: LKK
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening