Description of Event or Problem · 1
PATIENT CALLED TO REPORT THAT HE FELT UNWELL FOR SEVERAL WEEKS AFTER HIS ICD WAS CHECKED IN 2007 AND THAT HE ENDED UP IN THE HOSPITAL, WHERE HE FOUND OUT THAT SOMETHING IN HIS ICD WAS NOT TURNED ON. THE PATIENT DESCRIBED THAT, AND THAT THE BIOTRONIK REP "TURNED SOMETHING OFF TO DO TESTING AND FORGOT TO TURN IT BACK ON AGAIN." HE IS NOW SEEKING REIMBURSEMENT FOR HIS HOSPITAL EXPENSES, INCLUDING TRANSPORT FROM ONE HOSPITAL TO ANOTHER. REGULATORY CONTACTED PATIENT AND SALES REPRESENTATIVE. PATIENT CONFIRMED, THAT HE HAD BEEN ADMITTED TO THE INTENSIVE CARE UNIT AT THE HOSPITAL AND THAT THE BIOTRONIK SALES REPRESENTATIVE CAME INTO THE HOSPITAL LATE AT NIGHT. PATIENT INDICATED THAT THE SALES REPRESENTATIVE TURNED SOMETHING ON AND HE IMMEDIATELY FELT BETTER. SALES REPRESENTATIVE CONFIRMED THAT THE PATIENT WAS IN A PACEMAKER MEDIATED TACHYCARDIA AND AS SOON AS PMT PROTECTION WAS TURNED ON, THAT HE IMMEDIATELY BEGAN TO FEEL BETTER. SALES REP LATER CHECKED THE PATIENT'S RECORDS AND DETERMINED THAT PMT PROTECTION HAD NEVER BEEN ACTIVATED FOR THIS PATIENT BEFORE THE EVENT DESCRIBED ABOVE.