MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A.; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number UNK PROGRAMMABLE VALVE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Udi -- unknown.No product information provided.It has been reported that the device remains implanted; therefore it is not available for evaluation.Attempts are being made to obtain additional device information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the sales rep, on x-ray, it appears that the valve's stator became dislodged.Initially the pas were unable to read the valve.Another image was taken to see if they could get a better reading.No adverse consequences were reported.To date there has been no treatment or revision for this event.

Manufacturer Narrative

It has been communicated that the device remains implanted.To date, no additional intervention or revision has been performed.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.X-ray images were provided for evaluation; however, no conclusion could be reached based on those images.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information 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.

• Brand Name: NI
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29 case postale; le locle ; SZ
• MDR Report Key: 7338819
• MDR Text Key: 102585373
• Report Number: 1226348-2018-10206
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other