MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLIN VLV ONLY W/SPHNGD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8804

Device Problems Material Rupture (1546); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reported valve was implanted to a hydrocephalus patient via lp-shunt (doi and the initial setting are unknown).The surgeon lowered the pressure setting when the patient came to the hospital for checkup because the patient¿s symptom got worse.However, the patient¿s condition didn¿t improve even after lowering the valve¿s pressure.The surgeon found rupture at the lumbar catheter, and also suspected drainage malfunction of the valve on (b)(6) 2017.A revision surgery is scheduled on (b)(6) 2017.The sales force scheduled an interview the surgeon in the week of (b)(6) 2017 and will collect more detail.No further information was provided by the hospital.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6527181
• MDR Text Key: 73866695
• Report Number: 1226348-2017-10282
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112156
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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