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

Catalog Number 82-3190

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Once the system was turned on, the message "under refrigeration" came out at the outpatient department on (b)(6) 2017.Neither surgical delay nor adverse consequence to the patient was reported.No further information was provided by the hospital.

Manufacturer Narrative

The product was received in codman (b)(4).Inspection in codman (b)(4) reported that an error message displayed "programmer failure need service".Device has been reset, checked and returned to customer.A dhr review was performed for the programmer 82-3190, s/n: (b)(4) (lot# ckdc9b), and the lot met specifications when released on march 26th, 2009.The release quantity was (b)(4).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: CODMAN HAKIM PROGRAMMER
• 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: 6849682
• MDR Text Key: 86288991
• Report Number: 1226348-2017-10668
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3190
• Device Lot Number: CKDC9B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1