MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS PLUS INLINE VALVE ONLY; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8800PL

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Failure of Implant (1924)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

The device has been returned and is awaiting evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the rep, after eight months, a certas plus valve had unintended setting changes and was revised.The valve will be returned.

Manufacturer Narrative

The device was returned for evaluation.The position of the cam when the valve was received was at setting 3.The valve was visually inspected; no defects were noted.The valve was tested for programming and passed.The valve was flushed; no occlusions were noted.The valve was leak and reflux tested without issue.The siphon guard was tested and passed.The valve was dried.The siphon guard was removed.The valve was then pressure tested and passed.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8156994
• MDR Text Key: 130175716
• Report Number: 1226348-2018-10874
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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: 82-8800PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR