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

Model Number 8637-40

Device Problems Component Missing (2306); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 15-aug-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 a manufacturer¿s representative (rep) regarding the implantable drug infusion device.The drug being delivered was 5 mg/ml infumorph at 0.33 mg/day.It was reported that the collette was defective.A portion of the collette was missing.There were no environmental, external or patient factors that may have led or contributed to the issue.Actions taken to resolve the issue included replacing the catheter with new device.The catheter was never implanted.The event occurred on (b)(6) 2020.The issue was resolved at the time of the report.There were no symptoms reported.There were no further complications reported/anticipated.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer¿s representative on (b)(6) 2020.It was reported that the catheter would be returned for analysis.The pump serial number was also provided.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id: 8780, lot#/serial# (b)(6), 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.

Manufacturer Narrative

Continuation of d11: product id: 8780, serial# (b)(6), product type: catheter.H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing.Analysis identified the collet was detached/missing from the connector.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.

Event Description

The catheter was returned for analysis.

• 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 MN 00777
• MDR Report Key: 10179664
• MDR Text Key: 196102417
• Report Number: 2182207-2020-00392
• Device Sequence Number: 1
• Product Code: LKK
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Weight: 102