MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY MEDTRONIC EDM LUMBAR CATHETER, CLOSED TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Lot Number 0224133941

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Spinal drain that was placed in the operating room did not drain any csf during the early post-op phase.Md attempted to aspirate csf from the drain without success but was able to flush the drain with 2 cc of normal saline.Md slowly pulled drain back 2 cm and attempted to aspirate without success.Md decided to remove drain and in doing so encountered resistance.Md proceeded slowly and was able to pull back another 2 cm before the drain snapped at the 10 cm mark.The proximal end retracted into the soft tissue of the patient."(b)(6)".Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC EDM LUMBAR CATHETER, CLOSED TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 15183926
• MDR Text Key: 297685670
• Report Number: MW5111324
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0224133941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White