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

Catalog Number UNKNOWN-S

Device Problems Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Visual Impairment (2138); Vomiting (2144)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.All valves are 100% tested at the time of manufacture.

Event Description

It was reported to medtronic neurosurgery that the patient was currently implanted with two lumbar shunts and a ventriculoatrial (va) shunt.According to the report, the va shunt was toggling between 2.0 and 1.5 and there was overdrainage.Reportedly, the patient experienced severe side effects from the shunts.It was stated she experienced vision impairment, severe headaches, nose bleeds, vomiting, a burning feeling in the shunt area, and at times, numbness on the same side of her face as the shunt.The physician was reportedly going to try and flush the valve out to see if there was any biological debris affecting the setting.It was unknown if the two lumbar shunts were produced by the manufacturer.

Manufacturer Narrative

Additional information received reported that the patient had spent most of the day in the emergency room (er) on (b)(6) 2017.It was stated that all 3 of the patient's shunts were malfunctioning.About 2 weeks later, the surgeon decided to replace the device with a new one.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: STRATA II 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, CA 55432 ; 7635260594
• MDR Report Key: 6473419
• MDR Text Key: 72187836
• Report Number: 2021898-2017-00174
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Weight: 100