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

Catalog Number 42365

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

Patient Problems Unspecified Infection (1930); Therapeutic Response, Decreased (2271); Coma (2417)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

The returned valve was patent.It met the requirements for pressure-flow, and pre-implantation.However, it did not meet requirements for reflux testing.Proteinaceous debris was noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux.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 valve also did not meet the requirements for leak testing due to multiple tears observed in the top of the reservoir.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.¿ 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 device was implanted in (b)(6) 2015 due to hydrocephalus.According to the report, from 2015 to 2016, the pressure level of the device changed by itself several times causing poor flow, increased intracranial pressure, an intracranial infection, and a coma.Reportedly, the patient underwent hospitalization and the device was explanted and replaced.The report stated that the patient¿s current status is stable.

Manufacturer Narrative

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

• Brand Name: STRATA NSC 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: 6125915
• MDR Text Key: 60843282
• Report Number: 2021898-2016-00431
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033850
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42365
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 64