MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II, ADJUSTABLE PRESSURE VALVE, ID CARD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENT

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

My letter of (b)(6) 2018, the problem with the medtronic shunt card is obvious due to lack of specific info that the lay person has no access to: p/l setting, shunt / valve / reservoir, proximal catheter, distal catheter, on the back of the card there are five strata ii shunts, "which one does (b)(6) have?" "how can recalls be identified, as in the stratamr adjustable valves and shunts be identified by implant pts and caregivers if there are no serial or lot numbers provided?".

• Brand Name: STRATA II, ADJUSTABLE PRESSURE VALVE, ID CARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENT
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 7797339
• MDR Text Key: 117795752
• Report Number: MW5079233
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 54