Description of Event or Problem · 1
PT HAD SYRINGOMYELIA TREATED BY SYRINX TO PERITONEAL CAVITY SHUNT. FOLLOWING INSERTION OF THE SHUNT SHE WAS ADMITTED TO A NURSING HOME FOR PHYSICAL REHABILITATION. SHE SUBSEQUENTLY SUFFERED FROM PROGRESSIVE, PAINFUL, LOWER EXTREMITY SPASMS. SHE WAS TREATED WITH LIMITED SUCCESS USING ORAL BACLOFEN. IT WAS RECOMMENDED TO HER THAT SHE HAVE A MEDTRONIC INFUSION PUMP IMPLANTED FOR INTRATHECAL DELIVERY OF BACLOFEN. A MEDTRONIC SYNCHROMED II 8637-20, SERIAL NUMBER (B)(4), PUMP WAS IMPLANTED ON (B)(6) 2006. INITIALLY, THE PT DID REASONABLY WELL. HOWEVER, AS TIME PASSED, AS WE RECALL IN EARLY (B)(6), SHE DEVELOPED CLASSIC SYMPTOMS OF BACLOFEN WITHDRAWAL, INCLUDING SEVERE VISUAL HALLUCINATIONS, DELUSIONS, CONFUSION, AGITATION, DELIRIUM, DISORIENTATION, PERCEPTUAL DISTURBANCES, ANXIETY, AND RESTLESSNESS. SHE BECAME UNCONTROLLABLE AND WAS READMITTED TO THE HOSPITAL WHERE ATTEMPTS AT TREATMENT INCLUDED REPROGRAMMING THE PUMP. HER SYMPTOMS NEVER REALLY DID RESOLVE AND SHE WAS SENT BACK TO THE NURSING HOME WHEN SHE BECAME PROGRESSIVELY SOMNOLENT AND THEN EXPIRED ON (B)(6) 2006. A POSTMORTEM EXAM, INCLUDING A NEUROPATHOLOGICAL EXAM, WAS PERFORMED ON (B)(6) 2006. NO SIGNIFICANT CONTRIBUTORY FINDINGS WERE PRESENT. IMPORTANTLY, THE MEDTRONIC PUMP WAS IN PROPER POSITION AND THE INTRATHECAL CATHETER WAS APPROPRIATELY PLACED. WE RECENTLY READ ABOUT THE CLASS I RECALL OF THIS PARTICULAR DEVICE AND FELT IT IMPORTANT TO REPORT THIS PARTICULAR PT, EVEN THOUGH SEVERAL YEARS HAVE PASSED SINCE THE DEMISE OF THIS PT. I AM REPORTING AS THE PT'S SON-IN-LAW. I AM A RETIRED ORTHOPAEDIC SURGEON.