MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULOSTOMY RESERVOIR ASSEMBLY; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	27051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned ventriculostomy reservoir assembly was patent.However the device did not meet leak testing due to a broken base.It is unknown how or when the damage occurred.The instructions for use that accompany the device caution that ¿snap shunt type products may disconnect at the plastic snap junction if they are: damaged prior to connection; connected, disconnected and reconnected; or not completely connected during implant.Proteinaceous debris was observed on the exterior of the ventriculostomy reservoir assembly.A review of the manufacturing records showed no anomalies.All reservoirs are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device failed after implant.According to the report, the tip of the snap reservoir had broken off.Reportedly, the device was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICULOSTOMY RESERVOIR ASSEMBLY
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6408368
• Report Number: 2021898-2017-00112
• Device Sequence Number: 18840644
• Product Code: JXG
• UDI-Device Identifier: 00643169498198
• UDI-Public: 00643169498198
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K874498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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: 01/31/2021
• Device Catalogue Number: 27051
• Device Lot Number: E09976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 17 YR
• Patient Weight: 84