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

Catalog Number 82-3184

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 04/08/2015

Event Type  Injury  

Event Description

Stopped functioning after implantation.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was 60mmh2o.The valve was visually inspected; needle holes in the needle chamber were noted, the valve was irrigated with purified water; no occlusion was noted.The bactiseal catheter was irrigated with purified water, no occlusion noted.The valve was dried.The valve was leak tested.Leaks were noted form the needle holes in the needle chamber.The valve was reflux tested, the valve passed the test.The valve was tested for programming.The valve passed the test.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve, product code 82-3184 with lot number crbdcw, conformed to the specifications when released to stock on the 17th march 2014.Review of the history device records confirmed the catheters, product code 82-3072, with lot number crhb7h, conformed to the specifications when released to stock on the 26th june 2014.No root cause could be determined as the valve functioned.No root cause could be determined as no defects were found with the bactiseal catheter.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: HAKIM PROGRAMMABLE VALVE, RT ANGLE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4757523
• MDR Text Key: 18288647
• Report Number: 1226348-2015-10269
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 82-3184
• Device Lot Number: CRBDCW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2014
• 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
• Treatment: 823072
• Patient Outcome(s): Required Intervention