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); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problem Twiddlers Syndrome (2114)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2020, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2020-june-19, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving an unknown drug via an implantable pump for non-malignant pain.It was reported the patient's pump was flipping in the pump pocket and the managing physician had been getting higher than expected residual volumes at refills.There were no known environmental, external, or patient factors.No specific diagnostics were done other than the higher than normal volumes and ability to manually flip the pump in the pocket.The patient was scheduled for a pocket revision and possible catheter replacement on (b)(6) 2020.The issue was not resolved at the time of this report.The patient's status was alive - no injury.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter; product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot# (b)(4), ubd 2021-11-07, udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that upon removal and replacement of catheter, it was evident that the catheter had become completely coiled and kinked in the pocket from suspected pump flipping.The issue was resolved at this time.No further complications were reported regarding the event.

Manufacturer Narrative

Continuation of d11: product id 8780, serial# (b)(6), implanted: (b)(6) 2020, explanted:(b)(6) 2020, product type: catheter; product id 8780, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.H3: the catheter was analyzed and found to be twisted.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: 10181749
• MDR Text Key: 196066549
• Report Number: 3004209178-2020-10789
• 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,Followup
• Report Date: 08/05/2020

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: 01/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/17/2020; 08/03/2020
• Supplement Dates FDA Received: 07/21/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention