MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STANDARD, 5 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27065 B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a ventricular catheter broke off from the valve into the ventricle, and the doctor was unable to retrieve the catheter from within the patient's ventricle.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.

• Brand Name: INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STANDARD, 5 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9954955
• Report Number: 2021898-2020-00118
• Device Sequence Number: 16753441
• Product Code: JXG
• UDI-Device Identifier: 00643169483897
• UDI-Public: 00643169483897
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K940096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 27065 B
• Device Catalogue Number: 27065 B
• Device Lot Number: E40224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 MO
• Patient Weight: 10