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

Model Number	8781
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Information was received from healthcare provider (hcp) via manufacturer representative (rep) regarding a patient receiving fentanyl (2500 mcg ml/320 mcg day) via an implantable pump.It was reported that the catheter was not working.The patient healthcare provider (hcp) tried to aspirate through the side port upon the patient complaining he was no longer getting adequate pain relief.She was not able to obtain fluid through the side port.The patient hcp scheduled surgery for (b)(6) 2022 and tried to aspirate from the pump side port in surgery and was also not able to aspirate so he explanted the old catheter and implanted a new 8781 ascenda catheter.The old catheter was x planted in a new catheter was implanted.There was no environmental factor/patient factor.The patient¿s medical history and weight was asked but unknown.The patient status was alive-no injury.The issue was resolved.
Event or Problem Description
Information was received from healthcare provider (hcp) via manufacturer representative (rep) regarding a patient receiving fentanyl (2500 mcg ml/320 mcg day) via an implantable pump.It was reported that the catheter was not working.The patient healthcare provider (hcp) tried to aspirate through the side port upon the patient complaining he was no longer getting adequate pain relief.She was not able to obtain fluid through the side port.The patient hcp scheduled surgery for (b)(6) 2022 and tried to aspirate from the pump side port in surgery and was also not able to aspirate so he explanted the old catheter and implanted a new 8781 ascenda catheter.The old catheter was x planted in a new catheter was implanted.There was no environmental factor/patient factor.The patient¿s medical history and weight was asked but unknown.The patient status was alive-no injury.The issue was resolved.
Additional Manufacturer Narrative
Continuation of d10: product id 8637-40 serial# (b)(6) implanted: (b)(6) 2021: product type pump it was accidentally reported on the catheter before.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: ASCENDA
• Common Device Name: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15449106
• Report Number: 3004209178-2022-12045
• Device Sequence Number: 18020263
• Product Code: LKK
• UDI-Device Identifier: 00763000051129
• UDI-Public: 00763000051129
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 09/19/2022
• Date Device Manufactured: 11/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male