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

Catalog Number UNKNOWN-SMR

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

The product testing is in progress.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 the device was explanted.According to the report, they had to ¿flush hard¿ through the valve in order to start flowing a little.Reportedly, the distal and ventricular catheter worked fine.

Manufacturer Narrative

The returned valve was patent.Therefore the conditions of the complaint could not be duplicated by laboratory personal.The valve was returned at pl 1.0 and was not adjustable; therefore, siphon, reflux, pressure-flow and pre-implantation testing are precluded.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may interfere with the adjustment mechanism resulting in difficulty adjusting the valve.The instructions for use 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 did not meet requirements for leak testing due to a tear 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.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: UNKNOWN STRATAMR 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: 6465572
• MDR Text Key: 72060079
• Report Number: 2021898-2017-00158
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-SMR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• 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: N
• Removal/Correction Number: 2021898-022217-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 MO