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

Catalog Number 42866

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for siphon, reflux, pressure flow, and preimplantation testing.The valve did not meet requirements for leak testing due to a tear in the top of the delta chamber.It is unknown how or when this damage occurred.The ifu cautions that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also cautions that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ proteinaceous debris was observed within the interior and exterior of the valve.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.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.

Event Description

It was reported to medtronic neurosurgery that overdrainage occurred with the patient's device even at the performance level 2.5.According to the report, the device was explanted and replaced.Reportedly, there was no injury to the patient.

Manufacturer Narrative

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

• Brand Name: STRATA II VALVE, REGULAR
• 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: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6450940
• MDR Text Key: 71457702
• Report Number: 2021898-2017-00143
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42866
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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