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

Lot Number 0219498721

Device Problem Defective Component (2292)

Patient Problems Adhesion(s) (1695); Arrhythmia (1721); Cerebrospinal Fluid Leakage (1772); Headache (1880); Failure of Implant (1924); Laceration(s) (1946); Loss of Range of Motion (2032); Depression (2361); Impaired Healing (2378); Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2020

Event Type  Injury  

Event Description

Caller called to report that she has had seven revisions with her shunt valve.She has experienced internal lacerations, frozen shoulder, adhesions, abdominal wounds that would never heal, csf leakage, headaches and increased pulse rate.She reports that she could feel sharp edges from the device in her abdomen.With each revision the surgeon would note that the device is defective, the pop off would not function correctly.When she should have 25 ml of pressure relief, she would get 3 ml.Reporter states that she was on bedrest for a year and was so depressed prior to her last surgery that she asked the doctor to let her die on the table.She no longer feels suicidal due to complete removal of the system and states that her life has improved but, she will never be the same.

Event Description

Add'l info received from reporter for report mw5109804; reporter calling back to state she continues to have neurological problems/deficits caused by defective implanted devices.She also has lot numbers on devices.

Event Description

Additional information received from reporter for mw5109804.Reporter calling to add that the defective valves would self-adjust, resulting in "spewing of csf fluid" into her abdomen.(b)(4).

• Brand Name: STRATA LP SHUNT VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 14469022
• MDR Text Key: 292363217
• Report Number: MW5109804
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 0219498721
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: ATIVAN ; HYPERTENSION MEDICATION
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening; Other
• Patient Age: 51 DA
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: White