MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA BURR HOLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42836
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
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 strata ii valve was leaking.It was confirmed that there was no patient impact as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received indicating that the notify date of the event was on (b)(6) 2018.It was also clarified that the valve was leaking at the seam so it was explanted on (b)6) 2018.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the valve was implanted on (b)(6) 2018.It was stated once the shunt was put in place, the surgeon noticed the valve was leaking around the base.The manufacturer representative observed it to be leaking also.The surgeon called for another valve, and he placed it in 5-10 minutes.There was no outside or patient factors as well as no needles or sharps involved with this event.

• Brand Name: STRATA BURR HOLE VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7266245
• Report Number: 2021898-2018-00083
• Device Sequence Number: 13821861
• Product Code: JXG
• UDI-Device Identifier: 00643169840959
• UDI-Public: 00643169840959
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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: 12/31/2019
• Device Model Number: 42836
• Device Catalogue Number: 42836
• Device Lot Number: E26450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018; 04/25/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 02/13/2018; 04/26/2018
• 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: 76 YR