MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 27819

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to medtronic neurosurgery that the disease expected to be treated was craniocerebral trauma.According to the report, on (b)(6) 2017, the patient had right brain skull repair and left brain shunt placement.Before the surgery, the patient's lumbar puncture pressure was 300, and the implanted valve pressure was set at 2.5.After 2 days, the ventricle didn't decrease, and the physician adjusted the pressure to 2.0 on (b)(6) 2017.It was stated the ventricle still didn't reduce.On (b)(6), 2017, the physician adjusted the pressure to 1.5, but the film showed no reduction in cerebrospinal fluid.On (b)(6) 2017, the physician adjusted the pressure to 1.0 but was still ineffective.On (b)(6) the physician finally adjusted the pressure to 0.5.Reportedly, during this period, the pressure was normal.The patient's family repeatedly pressed the valve position, and the elasticity of the valve was good.The physician pressed the valve position, and the elasticity was good and both ends of the catheter were not blocked, but there was not normal drainage.The patient wasn't improving, and the doctor measured the lumbar puncture pressure to be at 400 on (b)(6) 2017.It was stated the patient had surgery to explant the terminal end of the abdominal cavity device on (b)(6) 2017.Needles did not pump out the liquid, and the patient was connected to a drainage bag and had an external drainage.After the surgery, the patient's condition improved.

Manufacturer Narrative

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.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for siphon, and pre-implantation testing.However, the device did not meet the requirements for reflux and pressure-flow testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux and affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ the returned valve also did not meet the requirements for leak testing due to a tear observed in the top of the reservoir.It is unknown how or when this damage occurred.The ifu caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, WITH BIOGLIDE
• 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: 6645067
• MDR Text Key: 77704544
• Report Number: 2021898-2017-00323
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169010499
• UDI-Public: 00643169010499
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 27819
• Device Lot Number: E11602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 43