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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2020, product type: catheter.Product id: 8784, serial#: (b)(4), implanted: (b)(6)2020, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 07-apr-2016, udi#: (b)(4).Product id: 8784, serial/lot #: (b)(4), ubd: 06-nov-2021, 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 dilaudid (2.7mgm/ more at.041/day) and bupivacaine (35mg/ml at 5.3mg/day) via intrathecal infusion pump for non-malignant pain.It was reported the patient had withdrawal symptoms.At some point within the last week the hcp attempted to aspirate the catheter unsuccessfully.The patient admitted to flipping the pump in its pocket.The pump pocket was opened today to find a coiled catheter.The catheter was uncoiled but csf flow didn¿t return.The catheter was replaced.The issue was resolved at the time of this report.

Event Description

Additional information was received from a healthcare provider via a company representative.The date of the event regarding the pump having been flipped was unknown.The pump flipping and withdrawal symptoms were resolved.Regarding the pump, it was noted as having been still in use.

Manufacturer Narrative

H6 correction: the device code c62968 was not previously indicated in error.The previously applied method code 4115, results code 3221, and conclusion code 67 remain applicable to the catheter components.The previously applied method code 4117, results code 3221, and conclusion code 22 remain applicable to the pump.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: 10642428
• MDR Text Key: 215031998
• Report Number: 3004209178-2020-17409
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR