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

Model Number 8637-40

Device Problems Component or Accessory Incompatibility (2897); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Deposits (1809); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4).Implanted: (b)(6) 2008.Product type: catheter, product id: 87 31, serial# (b)(4), implanted: (b)(6) 2008.Product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 29-nov-2009, udi#: (b)(4).Product id: 8731sc, serial/lot #: (b)(4), ubd: 14-jun-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via company rep regarding a patient receiving bupivacaine (3mg/ml at 1.199mg/day), morphine (30mg/ml at 11.99mg/day), and clonidine (150mcg/ml at 59.95mcg/day) via intrathecal infusion pump for non-malignant pain, failed back surgery, and peripheral neuropathy.It was reported that the patient¿s pump was replaced due to normal battery depletion, but the catheter had no csf backflow when disconnected from the existing pump.The hcp reconnected the catheter to the existing pump and was not able to aspirate any fluid via the cap either.The hcp cut the proximal end of the existing catheter and added an 8578 to the existing catheter.The hcp also tried doing a catheter dye study but the dye "did not go anywhere when it was injected".Fluoro was utilized during the procedure so caller said the needle was in the cap and the hcp utilized both needles with the two different attempts.Caller stated the hcp also noticed an inner pocket wall crystallization formation.The pocket was irrigated but the issue was not corrected.The rep was not aware of any previous reservoir volume discrepancies at pump refills.The circumstances that led to the reported issue were unknown.During troubleshooting it was reviewed that the incorrect revision kit was used for the existing 8731sc catheter.The issue was not resolved.The hcp closed the patient up, decreased the daily dosing of the it drugs and was going to recommend the patient follow up with their primary hcp.It was stated the plan was to perform a total catheter replacement once the hcp had consent.No symptoms were reported.

Event Description

Additional information received from a manufacturer representative indicated that the patient did not report any symptoms prior to the scheduled replacement and had used the pump for years without issue.They were not able to resolve the aspiration issues during the initial surgery, so the physician aborted the procedure and sent notes back to the referring physician.A dye study was going to be performed, but it was thought that it was ever done.The referring physician sent orders to have the entire system replaced together, and the replacement was completed.The cause of the aspiration and crystallization issues was not determined.The patient was seen by their managing physician after the replacement took place and everything was fine at that time.

Manufacturer Narrative

Continuation of d10: product id 8709, serial# (b)(6) implanted: (b)(6) 2008, explanted: (b)(6) 2020, product type catheter product id 8731sc, serial# (b)(6) , implanted: (b)(6) 2008, 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.

• 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: 10541406
• MDR Text Key: 207337716
• Report Number: 3004209178-2020-16069
• 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
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: 01/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR