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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Abdominal Pain (1685); Muscular Rigidity (1968)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 04-may-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving gablofen 2000mcg/ml at 1 ,100.5 mcg/day via an implantable pump.On (b)(6) 2020 it was reported that the patient was admitted to the hospital with acute abdominal pain and increased spasticity.The diagnostics and troubleshooting performed was a dye study and a rotor study.The physician could not aspirate the catheter during a catheter dye study and the rotor study showed that the rotors were rotating properly.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue.The actions and interventions taken to resolve the issue was a catheter exploration was scheduled for (b)(6) 2020.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, with injury- the patient had abdominal pain.No further complications were reported regarding the event.

Manufacturer Narrative

Product id: 8780.Serial# (b)(6).Implanted: (b)(6) 2015.Explanted:(b)(6) 2020.Product type: catheter.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.H6- device code: c62968 is also applicable to this event.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

Additional information was received from a company representative (rep) indicated the devices were received for analysis and the physician sheared the catheter during explant/replacement.No further complications were reported.

Manufacturer Narrative

H3: the pump was returned and passed all testing in the laboratory and no anomalies were identified.The catheter was returned and analysis identified an area of compression on the catheter body.Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2020 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: 10117885
• MDR Text Key: 194033276
• Report Number: 3004209178-2020-09683
• 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,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR