• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON / INTEGRA LIFESCIENCES CERTAS CODMAN SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

JOHNSON & JOHNSON / INTEGRA LIFESCIENCES CERTAS CODMAN SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Device Problem Missing Information (4053)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2018
Event Type  malfunction  
Event Description
I had a certas-codman ventricular-peritoneal shunt implanted (b)(6) 2017 from johnson and johnson at the (b)(6). This replaced a medtronic strata valve. Medtronic always supplies an id card for their implanted devices with technical info for pts to show radiologists and physicians for safety concerns during mra exams and tsa agents at airports as some devices trigger alarms. I have never received a card for the certas-codman valve, so i called j&j only to find out, the unit was sold to integra life sciences. I called integra but have not heard back from integra medical inquiry division. My complaint is with j&j and integra life sciences for failing to provide implanted device id cards.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCERTAS CODMAN
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
JOHNSON & JOHNSON / INTEGRA LIFESCIENCES
MDR Report Key8090645
MDR Text Key128191837
Report NumberMW5081503
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-