MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. STRATA II; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Lot Number 0217923546

Device Problems Defective Device (2588); Device Markings/Labelling Problem (2911)

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

Event Date 10/12/2020

Event Type  malfunction  

Event Description

A medtronic strata ii ventriculo-peritoneal (vp) shunt was implanted into a patient.Post-operatively, it was radiographically recognized that the valve lacked the radio-opaque markings required to confirm its orientation and pressure settings.In addition to this patient, another patient was implanted with a defective medtronic strata ii vp shunt valve on the same day [date redacted] at another hospital.After recognition of this implanted vp shunt valve defects, remaining medtronic strata ii vp shunt valves in inventory were radiographically tested while remaining in their unopened packaging.The devices in inventory were also found to be defective for the same reason ¿ no radiographic markings on the shunt valve.The lot numbers for these medtronic strata ii vp shunt valve devices were 0219081908 and 0218417810.

• Brand Name: STRATA II
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 10762468
• MDR Text Key: 213876144
• Report Number: 10762468
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0217923546
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 75