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

Catalog Number 82-3112

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Vomiting (2144); Alteration In Body Temperature (2682)

Event Date 09/26/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4) it was not possible to investigate the complaint as no samples were returned for evaluation.If the samples are returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the device product code 82-3112 with lot cpfbv7 conformed to the specifications when released to stock in 14th may 2013.Review of the sterilization certificate confirmed to the specifications when released on the 7th may 2013.Review of the history device records confirmed the device product code 82-3041 with lot cpgdc4 conformed to the specifications when released to stock in 1st october 2013.Review of the sterilization certificate confirmed to the specifications when released on the 23rd september 2013.Review of the history device records confirmed the device product code 82-3045 with lot cphblb conformed to the specifications when released to stock in 16th july 2013.Review of the sterilization certificate confirmed to the specifications when released on the 12th july 2013.At the present time this complaint is closed.Device not available.

Event Description

This is retrospective study for bactiseal catheter safety assessment.The medical history record was reviewed and it was found that the patient accepted v-p shunt on (b)(6) 2015.From early record it was noted the patient accepted v-p shunt on (b)(6) 2014.No anomaly occurred during operation.The patient temperature rose 37.8c.Anti-inflammatory treatment was done.The patient refused continuous treatment and he was discharged on (b)(6) 2014.On (b)(6) 2014 the patient vomited and returned hospital.It was reported abdominal abscess.The surgeon did external drainage on (b)(6) 2014.Finally the surgeon removed the catheter and changed the other brand product to complete procedure on (b)(6) 2014.The patient was discharged on (b)(6) 2015 and transferred to other hospital for continuous treatment.The surgeon's opinion is that it is related with product and procedure.

• Brand Name: HAKIM PROGRAMMABLE MICRO VALVE
• 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: 5928558
• MDR Text Key: 53924722
• Report Number: 1226348-2016-10629
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980778
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 82-3112
• Device Lot Number: CPFBV7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• 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: 82-3041; 82-3045
• Patient Outcome(s): Required Intervention