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

Model Number	8780
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient receiving int rathecal gablofen 500/mcg at a dose of 100mcg/day via an implantable pump for unknown indications for use.It was reported that the doctor had issues with the catheter shredding during an implant attempt.The patient had no symptoms or external issues.No troubleshooting or interventions were performed.The issue was resolved at the time of the report and the patient's status was "alive-no injury".The patient's weight and medical history was asked but was unknown.It was further reported that a surgical intervention did not occur and was not planned.Additional information received from a manufacturer representative (rep) indicated that the pump was not replaced on (b)(6) 2024.On (b)(6) 2024, they were implanting an entire new system.The rep further stated that there was nothing in the body, that was why they were implanting a new catheter on (b)(6) 2024.It was unknown as to why the catheter was shredding, possible needle issue or physician technique, but nothing was determined.All of the catheters referenced in the previous report were shredding.The rep also stated that they were not in possession of any attempted or removed product.
Additional Manufacturer Narrative
Continuation of d10: product id: 8780, serial# (b)(6) implanted: (b)(6) 2024, explanted: (b)(6) 2024, product type: catheter; product id: 8781, serial# (b)(6), implanted: (b)(6) 2024, explanted: (b)(6) 2024, product type: catheter; product id: 8781, serial# (b)(6), implanted: (b)(6) 2024, explanted: (b)(6) 2024, product type: catheter; product id: 8780, serial# (b)(6), product type: catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 15-mar-2026, udi#: (b)(4) ; product id: 8781, serial/lot #: (b)(4), ubd: 23-feb-2026, udi#: (b)(4); product id: 8781, serial/lot #: (b)(6) , ubd: 23-feb-2026, udi#: (b)(4); product id: 8780, serial/lot #: (b)(6) , ubd: 13-mar-2026, udi#: (b)(4) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received indicated that the previously reported information on 2024-05-09 was confirmed with the physician account.

• 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: 19293570
• Report Number: 3004209178-2024-10828
• Device Sequence Number: 8792004
• Product Code: LKK
• UDI-Device Identifier: 00763000051112
• UDI-Public: 00763000051112
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2026
• Device Model Number: 8780
• Device Catalogue Number: 8780
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/20/2024
• Date Device Manufactured: 03/13/2024
• 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 H11
• Patient Age: 65 YR
• Patient Sex: Male