FDA Adverse Event Injury Summary report: N

CODMAN HAKIM

MDR report key: 2113242 · Received May 26, 2011

Report

Report Number
MW5020814
Event Type
Injury
Date Received
May 26, 2011
Date of Event
May 1, 2011
Report Date
May 26, 2011
Manufacturer
JOHNSON & JOHNSON COMPANY
Product Code
JXG
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY (B)(6) FATHER WAS RECENTLY DIAGNOSED WITH NORMAL PRESSURE HYDROCEPHALUS AND UNDERWENT SURGERY TO INSTALL A CODMAN HAKIM PROGRAMMABLE SHUNT. NEUROSURGEON WAS DR (B)(6) OF (B)(6). FOLLOWING THE SURGERY, THE PRESSURE VALVE SETTING OF THE SHUNT REPEATEDLY CHANGED SPONTANEOUSLY DUE TO EXPOSURE TO MAGNETIC FIELDS IN THE PT'S HOME. OVERDRAINAGE RESULTED IN NEUROLOGICAL SYMPTOMS AND THE FORMATION OF A SUBDURAL HEMATOMA. DR (B)(6) PERFORMED TWO ADDITIONAL SURGERIES IN (B)(6) 2011 TO RESOLVE THE HEMATOMA AND THE PT RECOVERED. ON (B)(6) 2011, I BROUGHT A DC MAGNETOMETER TO MY FATHER'S HOME AND DISCOVERED THAT HIS CORDLESS TELEPHONES AND AUDIO HEADPHONES BOTH PRODUCED MAGNETIC FIELDS WELL IN EXCESS OF 150 GAUSS, THE APPROXIMATE THRESHOLD TO AFFECT THE SHUNT'S SETTINGS. I REMOVED THOSE DEVICES FROM THE HOME AND REPLACED THEM WITH DEVICES THAT PRODUCE MUCH SMALLER DC MAGNETIC FIELDS. IN THE WEEKS SINCE THEN, THE PRESSURE SETTING IN THE SHUNT HAS NOT SHOWN ANY SPONTANEOUS CHANGE. I HAVE HEARD THROUGH INFORMAL COMMUNICATION WITH OTHER NPH PTS THAT THIS TYPE OF PROBLEM IS RELATIVELY COMMON. PTS RECEIVING THE CODMAN HAKIM SHUNT NEED COMPREHENSIVE EDUCATION REGARDING DANGERS OF EXPOSURE TO DC MAGNETIC FIELDS FROM COMMON HOUSEHOLD DEVICES CONTAINING PERMANENT MAGNETS, SUCH AS TELEPHONES, AUDIO HEADPHONES AND EARBUDS. TELEPHONES, INTERCOMS, AND ANY OTHER ELECTRONIC DEVICES USED AT BEDSIDE IN THE HOSPITAL SHOULD BE CHECKED TO MINIMIZE PT EXPOSURE TO DC MAGNETIC FIELDS. A HOME VISIT FROM A HEALTH AID WITH A DC MAGNETOMETER WOULD BE VALUABLE TO IDENTIFY POTENTIAL HAZARDS. AS A LONGER TERM SOLUTION, FDA SHOULD REQUIRE THE MANUFACTURER TO REDESIGN THE DEVICE TO RENDER IT LESS SUSCEPTIBLE TO MALFUNCTION IN THE PRESENCE OF COMMON HOUSEHOLD DEVICES. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CODMAN HAKIM CODMAN HAKIM PROGRAMMABLE SHUNT VALVE JXG JOHNSON & JOHNSON COMPANY UNK

Patients

Seq Age Sex Outcome Treatment
1 79 YR Hospitalization| L| O| S