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

Catalog Number 0148CSD

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

Child was diagnosed 4months after shunt-placement ((b)(6)) with dysfunction ((b)(6)).During revision the problem was detected on valve-level.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the position of the cam when valve was received was 70mmh2o.The valve was visually inspected; no defects were noted.The valve was irrigated with purified water.No occlusion was noted.The valve was dried.The valve was leak tested, no leaks were noted.The valve was reflux tested, the valve failed the test.The valve was tested for programming.The valve failed the test, during the programming process the cam mechanism did not move.The valve was then pressure tested at 70mmh2o, the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism pillar, and on the base plate.The cam magnets were also controlled.The magnets passed.Review of the history device records confirmed the valve product code 0148csd, with lot ctbcc1, conformed to the specifications when released to stock on the 5th march 2015.The root cause of the problem found during investigation is due to biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism pillar, and on the base plate.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: STERILE MICRO PROGRAMMABLE VAL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5315319
• MDR Text Key: 34016457
• Report Number: 1226348-2015-10762
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK980778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 0148CSD
• Device Lot Number: CTBCC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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 Outcome(s): Required Intervention