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

Catalog Number 82-3190

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

Event Description

The ¿cooling-down¿ message was displayed right after turning on the power switch at the outpatient department.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.The product will not be returned to your site.

Manufacturer Narrative

It has been communicated that the device will not be returned; therefore, an evaluation of the device could not be performed.A review of manufacturing records for this serial number found not discrepancies.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be 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
• MDR Report Key: 7165225
• MDR Text Key: 96955845
• Report Number: 1226348-2018-10018
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K003564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1