MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL

Catalog Number UNK CERTAS PLUS

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable.The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a certas plus valve with siphonguard migrated, became inverted, after implant and could not be reprogrammed, then was revised.

Manufacturer Narrative

The device was returned for evaluation.The valve was visually inspected; no defects noted.The valve was tested for programming and passed.The valve was flushed; no occlusion was noted.The valve was leak tested; no leaks noted.The catheters were irrigated, no occlusions noted.A small tear/cut was noted in the ventricular catheter.The valve was reflux tested and passed.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested and passed.A review of manufacturing records could not be performed, as no lot number has been provided.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: NI
• Type of Device: NI
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 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: 8147752
• MDR Text Key: 129811141
• Report Number: 1226348-2018-10859
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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: No Information
• Device Catalogue Number: UNK CERTAS PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR