MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.

Catalog Number UNK VALVE

Device Problem Insufficient Information (3190)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown part number, udi unavailable.Complaint sample was not returned to codman and no product or 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.

Event Description

It was reported that the customer states that the settings have changed causing a shunt malfunction.The patient has had two concussions because of the shunt.

• Brand Name: NI
• Type of Device: NI
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8392498
• MDR Text Key: 137887678
• Report Number: 1226348-2019-10159
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR