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

Model Number 8780

Device Problem Retraction Problem (1536)

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

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of the catheter (sn; (b)(4) ) identified an anomaly to the catheter / guidewire.Damage occurred to the catheter body and/or guidewire during implant procedure.Concomitant medical products: product id: 8637-20, serial# (b)(4), product type: pump.Product id: 8780, serial# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider and a consumer via a company representative regarding a patient receiving morphine 1mg/ml at approximately.78mg/day via an implantable pump.The other medications the patient was taking at the time of the event was hydrocodone.It was reported that at the initial pump and catheter implant procedure the catheter was implanted/explanted.The physician placed the catheter intrathecal via the spinal needle in the 8780 kit.When attempting to remove the spinal needle, after the placement of the catheter, the physician could not remove the spinal needle without pulling the catheter with the needle.The doctor struggled trying to keep the catheter in place while removing the spinal needle and in doing so was not confident the integrity of the catheter was good.Therefore, the doctor requested another 8780 catheter to be opened and used.The first 8780 catheter used was not implanted.This was not a replacement or revision pump/catheter procedure.This was the initial pump and catheter placement for the patient.Two catheters were opened for the case.One catheter was implanted and then explanted.The other catheter was i mplanted.The environmental, external or patient factors that may have led or contributed to the issue was the physician stated the catheter was stuck to the spinal needle.This prevented the spinal needle from being removed appropriately.The spinal needle could not be removed without removing the catheter with it.The doctor was concerned with the integrity of the catheter and asked for a second catheter to be opened.The diagnostics and troubleshooting performed was the entire catheter was removed and a new catheter was opened and implanted.The initial starting dose the day of the pump implant (b)(6) 2020 was 0.5mg/day.The patient had two follow up appts in which the pump was increased 25% each visit.The doctor is concerned the patient has hyper-analgesia because the patient is claiming to not having any pain relief with the pump increases.The doctor instructed the patient to stop taking oral hydrocodone.The doctor has decided to do a catheter dye study on (b)(6) 2021 to confirm placement of the catheter.The issue is resolved at the time of the report.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11628528
• MDR Text Key: 247211635
• Report Number: 3004209178-2021-05623
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000051112
• UDI-Public: 00763000051112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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
• Patient Age: 58 YR