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

Model Number 8781

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 28-mar-2023, udi#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021 product type: catheter.The guidewires were returned and analysis found an anomaly to the catheter/guidewire.It was clarified that damage was observed in the catheter body and/or guidewire during the implant procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, foreign healthcare provider) regarding a patient who was receiving baclofen of an unknown concentration at an unknown dose rate via an implantable pump for unknown indications for use.It was reported that during a new intrathecal baclofen (itb) implant, both ascenda guide wires were found to be damaged / frayed after spinal segment placement.The first ascenda with serial number (b)(4) was not implanted, while the second with serial number (b)(4) was implanted, but both guide wires were to be sent for analysis.It was further reported that the neurosurgeon preferred not to use the first catheter (serial number (b)(4)) considering the positioning difficulties, so she used / implanted a second ascenda (serial number: (b)(4)), but even in this case the guide wire was damaged once removed.Environmental/external/patient factors that may have led or contributed to the issue was noted as being unknown.The issue was resolved at the time of the report.The patient was without injury regarding their status as of (b)(6) 2021.The patient's gender, weight, medical history, and age at the time of the event were unknown or would not be made available.

• Brand Name: ASCENDA
• 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
• 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: 14161305
• MDR Text Key: 289743233
• Report Number: 3004209178-2022-05010
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: 0222537281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1