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

Catalog Number 82-3116

Device Problem Decrease in Pressure (1490)

Patient Problem No Information (3190)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) it has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

Patient with shunt had mri and valve changed to high pressure setting during mri, vpv reprogramming post mri to set it back at original 70 setting, and the pressure setting got stuck at bottom level, 30.Valve is stuck on setting 30, ideal setting should be 70.Doctor was ok with setting 30 as it isn't too far off from ideal 70.

• Brand Name: HAKIM PROGRAMMABLE VALVE MICRO W/RICKHAM
• 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: 5018955
• MDR Text Key: 23615805
• Report Number: 1226348-2015-10478
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK980778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• 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
• Patient Age: 11 YR