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

Model Number 8637-40

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8596sc, lot/serial#: (b)(4).Implanted: (b)(6) 2010, product type: catheter, ubd: 15-mar-2,012, udi#: (b)(4).Product id: 8709sc, lot/serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type: catheter, ubd: 20-jul-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (2000 mcg/ml at 626 mcg/day) via an implantable pump for intractable spasticity and multiple sclerosis.It was reported that the patient was having withdrawal symptoms that seemed intermittent.  the pump logs were read and came back normal.A side port aspiration was attempted on (b)(6) 2021 but the healthcare provider was not able to aspirate, prompting replacement surgery on (b)(6) 2021.In surgery, it was noted that aspiration of the existing catheter could not be done.The doctor noted a kink at the anchor site in the spinal incision.Relaxing the kink allowed slow aspiration.The doctor then cut the catheter distal to the anchor and observed spontaneous flow.The old spinal segment was left in place and tied off and a new 8780 was then implanted.The pump was also replaced despite no known issues as it was nearing eri (elective replacement indicator) as well.  there were no environmental/external/patient factors that may have led or contributed to the kink.The issue was resolved.It was noted the catheters had already been sent back for analysis.

Manufacturer Narrative

H3 ¿ analysis of the pump found ¿motor feed thru anomaly ¿ shorting across insulator¿.The returned portion of the catheter was returned in 2 segments.Analysis of catheter model 8596sc found ¿sutureless connector ¿ coring/tears/cuts in seal ¿ no leak seen in lab¿.Analysis of the returned portion of catheter model 8709sc found ¿acceptable catheter testing ¿ catheter incomplete/returned in segments¿.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
• MDR Report Key: 11651792
• MDR Text Key: 245988145
• Report Number: 3004209178-2021-05862
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1579-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 77