NI

Additional Manufacturer Narrative

UDI -- UNKNOWN PART NUMBER, ATTEMPTS ARE BEING MADE TO OBTAIN, CURRENTLY THE UDI IS UNAVAILABLE. IT HAS BEEN REPORTED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. UPON RECEIPT OF THE DEVICE OR ADDITIONAL RELEVANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED FROM BIOMARIN, THAT A PATIENT HAD AN IMPLANTATION OF AN INTRACEREBRAL RICKHAM VENTRICULOSTOMY (ICV) SET (CODMAN SHURTLEFF GENERIC ICV DEVICE). THE LOT NUMBER AND MODEL NUMBER WERE NOT REPORTED. ON AN UNSPECIFIED DATED, MAGNETIC RESONANCE IMAGING CONFIRMED THAT THE DEVICE WAS PLACED IN THE WRONG POSITION. THE PATIENT HAD A REVISION SURGERY TO CORRECT THE PLACEMENT OF THE ICV DEVICE. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE REPORTER ASSESSED THE EVENT OF DEVICE DEPLOYMENT ISSUE AS NOT RELATED TO TREATMENT WITH BMN 190. OTHER ETIOLOGICAL FACTORS INCLUDED WRONG PLACEMENT OF THE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, THE REPORT WILL BE UPDATED. THIS IS THE FIRST OF 2 DEVICES BEING REGISTERED; THE OTHER DEVICE IS REGISTERED AS (B)(4).

Additional Manufacturer Narrative

MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.