Description of Event or Problem · 1
THE PATIENT WAS ADMITTED VIA ED THREE DAYS AGO, WITH THE CHIEF COMPLAINT: "DEFIBRILLATOR KEEPS GOING OFF." THE PATIENT WAS IN RAPID ATRIAL FIBRILLATION AT THAT TIME, "WHICH NECESSITATED MULTIPLE ICD CHARGES AND SHOCKS IN RAPID SUCCESSION. THE CHARGE TIME EXCEEDED THE ALLOWANCE OF THE DEVICE AND THE END OF SERVICE INDICATOR WAS TRIGGERED: RECOMMENDATION IS TO PERFORM AN ICD GENERATOR CHANGE/REPLACEMENT SINCE THE ICD WILL NOT FUNCTION PROPERLY." THE ICD WAS EXPLANTED AND ANOTHER ICD IMPLANTED. THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE PATIENT'S OUTCOME FROM THE EP PERSPECTIVE WAS SATISFACTORY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE PHYSICIAN BELIEVES THAT THIS WAS THE SENTINEL EVENT THAT LEAD TO THE MEDTRONIC NOTICE.====================== MANUFACTURER RESPONSE FOR ICD, SECURA======================"...MEDTRONIC WILL BE INFORMING PHYSICIANS OF A RARE DEVICE SOFTWARE ISSUE IN OUR CURRENT ICD AND CRT-D DEVICES. THE GOOD NEWS IS THAT THIS ISSUE CAN BE RESOLVED BY A SOFTWARE DOWNLOAD INSTALLED VIA THE PROGRAMMER. AS OF APRIL 19TH, 2010, MEDTRONIC HAS 5 CONFIRMED REPORTS OUT OF APPROXIMATELY 144,000 DEVICES WORLDWIDE. NO PATIENT INJURIES OR DEATHS HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE. MEDTRONIC HAS IDENTIFIED THE ROOT CAUSE TO BE ASSOCIATED WITH A RARE AND SPECIFIC SEQUENCE OF EVENTS THAT MUST OCCUR WITHIN MILLISECONDS OF EACH OTHER. MEDTRONIC ESTIMATES THAT THE RATE OF OCCURRENCE OF THIS SPECIFIC SEQUENCE OF EVENTS RESULTING IN EXCESSIVE CHARGE TIMES IN AN AMBULATORY SETTING TO BE 1 IN 27,000 DEVICES PER YEAR (.0000037 PER YEAR). WE WILL BE RESPONSIBLE FOR LOADING THE UPDATED SOFTWARE ON YOUR PROGRAMMERS AND WE ANTICIPATE THE SOFTWARE WILL BE FDA APPROVED IN THE NEXT FEW DAYS. ONCE THE SOFTWARE IS LOADED, UPON A PATIENTS' NEXT IN-CLINIC INTERROGATION THE DEVICE WILL RECEIVE THE UPDATE AND THEIR DEVICE WILL BE CORRECTED. DATED:05/05/2010