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

Model Number UNKNOWN-S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018 (hcp): it was reported that the healthcare professional stated the patient's valve was not holding pressure.They kept adjusting the valve, and it kept loosing its pressure.The shunt was implant on (b)(6) 2015, and the neurosurgeon was considering explanting and replacing.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the valve not holding pressure was first noticed (b)(6) 2018.It was stated that another doctor placed the valve on (b)(6) 2015.A shuntogram was performed and dye pooled in the valve.The patient had surgery to replace the valve on (b)(6) 2018.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7658670
• MDR Text Key: 113026471
• Report Number: 2021898-2018-00315
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73