MAUDE Adverse Event Report: MEDTRONIC KIT SHUNT LUMBOPERITONEAL STRATA

Model Number 44421

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

Event Type  Injury  

Event Description

Patient undergoing procedure to remove a lumboperitonela shunt (inserted (b)(6) 2016).The surgical team was able to expose and remove all but a portion of the catheter.As a result the patient required additional imaging to confirm the location of the remaining portion of the catheter and returned to the operating room the following day for removal of the retained portion.Dates of use: (b)(6) 2016.Reason for use: meningitis, hydrocephalus.

• Brand Name: KIT SHUNT LUMBOPERITONEAL STRATA
• Type of Device: SHUNT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5774791
• MDR Text Key: 49073740
• Report Number: MW5063242
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/01/2016

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 Model Number: 44421
• Device Lot Number: E05019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 50