MAUDE Adverse Event Report: MEDTRONIC, INC. ASCENDA PROXIMAL REV KIT OLD CATH; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Catalog Number 8784

Device Problems Unintended System Motion (1430); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Improper Flow or Infusion (2954); Material Twisted/Bent (2981)

Patient Problems Fall (1848); Head Injury (1879); Itching Sensation (1943); Pain (1994)

Event Date 10/16/2022

Event Type  malfunction  

Event Description

Customer was admitted due to sepsis through the emergency department.Customer is wheelchair bound at baseline due to spastic quadriplegia from an incomplete c5/6 spinal cord injury and has an implanted baclofen pump.Event: customer requested to get to the bathroom quickly and a hoyer lift was used to get customer on the toilet.Once customer finished with toilet, rn asked staff for help to get customer into the sling, and due to shift change, no one came.She decided to use the sling independently and customer slipped out of the sling, hit the floor hitting the back of her head on the floor and possibly left hip on the toilet.Customer was eventually assisted back to bed with 4 team members.Customer complained of head pain, ct ordered and was negative.After the fall, customer called the stroke center complaining of bad itchiness and feeling 'tight'.Stroke center nurse used aseptic technique to access the catheter access port of the customer's synchromed pump and was unable to aspirate fluid from the catheter.Customer was given oral baclofen and surgery was scheduled for the next day.Surgeon found likely traumatic displacement of the lumbar anchor with kinking of lumbar catheter.New intrathecal catheter was placed with continuation of intrathecal baclofen therapy.Contributing factors: sling was not appropriately positioned, the sling was not crossed at the customer's legs as demonstrated in all training that rn received.Rn did not follow protocol of two clinical staff members being present during use of lift.Transfer from bed to toilet was performed independently by rn.

• Brand Name: ASCENDA PROXIMAL REV KIT OLD CATH
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 15868412
• MDR Text Key: 304338632
• Report Number: 15868412
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8784
• Device Lot Number: HG58J JW06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2022
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female
• Patient Weight: 56 KG