MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII

Catalog Number XXX- OSVII

Device Problems Increase in Pressure (1491); Obstruction of Flow (2423)

Patient Problems Cerebrospinal Fluid Leakage (1772); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device is unlikely to be returned to the manufacturer for analysis as it still is currently implanted in the patient.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.(b)(4).

Event Description

A patient reported that a lumbar osv ii valve system continued to become clogged by debris.The patient got at most six months before the shunt no longer drained.The shunt also leaked out into the surrounding skin or spinal space.The patient¿s surgeon drained 35 to 40 milliliter (ml) of spinal fluid from the skin above the shunt every two weeks.Additional information received from the patient on (b)(6) 2018 with the following: the most recent shunt was implanted on march 9th (year was not specified) and the prior one was on april 19th (year was not specified).The current shunt was malfunctioning and the patient was seeking help to find a device that will not become clogged.The patient stated her pain leading up to surgery she has learned to tolerate.It has been six months with the current shunt and the pressure became elevated due to an improper working shunt.Additional information has been requested.

Manufacturer Narrative

The device was not returned for evaluation.No traceability information is available therefore no device history records review could be performed.The complaint is unverifiable, exact root cause could not be determined.

• Brand Name: OSVII
• Type of Device: OSVII
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 7934437
• MDR Text Key: 122678200
• Report Number: 9612007-2018-00029
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K092395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- OSVII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1