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

Catalog Number 82-3110

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 07/20/2017

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 an inph patient via vp-shunt (initial setting is unknown) on (b)(6) 2009.It was reported that the patient complained the difficulty with walking on (b)(6) 2017.Then, it was found that the abdominal catheter and valve distal connector were detached when the surgeon checked the valve condition under ct-scan.The revision surgery was performed on (b)(6) 2017.The surgeon confirmed that the implanted valve could flow properly, and then new abdominal catheter (82-3045) connected with the valve.The surgeon confirmed they were worked properly and the surgery was finished.The patient is (b)(6) years old, female, her initial is (b)(6), and her condition is under monitoring.The surgeon commented that he felt the connector of valve was shorter than usual.He suspected the connector was broken and might be remained in the removed abdominal catheter.The surgeon requested to investigate whether the broken connector remained at the removed abdominal catheter or not.No further information was provided by the hospital.

Manufacturer Narrative

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.

• Brand Name: HAKIM PROGRAMMABLE VALVE W/PRECHAMBER
• 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: 6788130
• MDR Text Key: 82506882
• Report Number: 1226348-2017-10567
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNKNOWN CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR