Description of Event or Problem · 1
IN 2007, PT RECEIVED THE IMPLANTATION OF AN ANS NEUROSTIMULATION DEVICE FOR CONTROL OF PAIN CAUSED BY MS BASED TRIGEMINAL NEURALGIA. AFTER USING THE DEVICE WITH QUESTIONABLE BENEFIT PT EXPERIENCED THE ONSET OF FACIAL PAIN THE FOLLOWING MONTH. THAT PAIN INCREASED TO A DEGREE THAT SHE HAD NEVER EXPERIENCED BEFORE THE IMPLANTATION. SHE ALSO BECAME DISORIENTED, REPEATING HERSELF, WITHOUT REALIZING SHE WAS DOING SO. THE DEVICE WAS OF NO HELP AND SEEMED TO MAKE MATTERS WORSE. ONLY MEDS, WELL BEYOND USUAL DOSAGES WERE OF SAME HELP. PT BECAME UNRESPONSIVE, WAS HOSPITALIZED, AND DIED TWELVE DAYS LATER, FROM RESPIRATORY FAILURE. RELATED TO NEEDED PAIN MEDS. PLEASE SEE LETTER OF 10/30/2007, ON FILE AND ATTACHED. ROUTE: IMPLANT, DATE OF USE: ONE MONTH IN 2007. DIAGNOSIS OR REASON FOR USE: MS BASED TRIGEMINAL NEURALGIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.