MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY MEDTRONIC PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 23047

Device Problem Crack (1135)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

Leak; patient received a ventriculoperitoneal shunt on (b)(6).Csf leakage noted on (b)(6) 2020, patient brought to surgery on (b)(6) and noted to that peritoneal catheter had crack in catheter where leakage of csf was noted.Peritoneal catheter (cat# 23047 lot# documented as na) replaced with new catheter.Not clear as to how or when crack occurred.

• Brand Name: MEDTRONIC PERITONEAL CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 10501553
• MDR Text Key: 206148558
• Report Number: MW5096460
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 23047
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR