Description of Event or Problem · 1
A PT HAD A REALIZE LAP BAND SYSTEM PLACED MORE THAN TWO YEARS AGO. THE PT WAS SCHEDULED FOR A PORT LOCATION REVISION DUE TO DISCOMFORT AT THE PLACEMENT SITE. THE ORIGINAL PORT WAS LOCATED AT THE PT'S WAISTBAND AND THE PT HAD RECENTLY BEGUN EXPERIENCING PAIN AND IRRITATION AT THE SITE. PRIOR TO THE PROCEDURE, BARIATRIC SURGEON NOTED THE SKIN AROUND THE PORT WAS VERY IRRITATED WITH ENCAPSULATION AND FAT NECROSIS. THE SURGEON MADE THE DECISION TO REMOVE THE ORIGINAL PORT AND REPLACE WITH ANOTHER AT AN ENTIRELY DIFFERENT LOCATION. ONCE THE SURGEON VISUALIZED THE ORIGINAL PORT, IT WAS NOTED THE TUBING STRAIN RELIEF COMPONENT OF THE REALIZE INJECTION PORT HAD BECOME DISPLACED FROM THE LOCKING MECHANISM AND HAD ACTUALLY MIGRATED FROM ITS ORIGINAL POSITION ON THE LOCKING MECHANISM. THE PORT AND THE TUBING WERE STILL CONNECTED AND IT IS NOT BELIEVED THAT THE TUBING STRAIN RELIEF COMPONENT IS FREE-FLOATING IN THE PT'S ABDOMEN, BUT RATHER HAS MIGRATED DOWN THE TUBING TOWARDS THE LAP BAND SYSTEM. THE SURGEON OPTED TO NOT EXPLORE THE TUBING ALL THE WAY DOWN TO THE LAP BAND ITSELF FOR FEAR OF COMPLICATING OR CAUSING DAMAGE TO THE PT'S ABDOMINAL TISSUE. THE SURGEON REPLACED THE PORT WITH A NEWER MODEL (SAME TYPE AND MFR), AND SECURED IT IN A DIFFERENT LOCATION. THE SURGEON DOES NOT FEEL THERE IS A CONNECTION BETWEEN THE SLIPPAGE OF THE TUBING STRAIN RELIEF COMPONENT AND THE PT'S DISCOMFORT WITH PORT PLACEMENT. THE IRRITATION WAS SIMPLY CAUSED BY CLOTHING RUBBING OVER IT REPEATEDLY AND ANATOMICAL BENDING AT THE SITE. OF NOTE, THERE WAS A RECALL OF THIS DEVICE RELATED TO THIS EXACT TOPIC IN OCTOBER OF 2010. THIS PORT HAS A LOT NUMBER OF ZJHBLB, SO IS DEFINITIVELY INVOLVED IN THE RECALL. MANUFACTURER ASSIGNED A COMPLAINT NUMBER TO THIS REPORT.