EMBLEM S-ICD
Report
- Report Number
- 2124215-2018-07699
- Event Type
- Death
- Date Received
- April 27, 2018
- Date of Event
- April 3, 2018
- Report Date
- June 18, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P110042/S043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE WAS RETURNED APPROXIMATELY 19 MONTHS LATER. THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. THE DEVICE WAS ABLE TO BE INTERROGATED AND A MEMORY DOWNLOAD WAS PERFORMED SUCCESSFULLY. DURING MANUAL TESTING, NO NOISE OR OVERSENSING WAS NOTED IN ANY OF THE THREE SENSE VECTORS. THE SENSING SIGNAL WAS PROPERLY DISPLAYED ON THE PROGRAMMER IN ALL THREE SENSE VECTORS. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO OUT OF RANGE MEASUREMENTS OR INTERRUPTIONS IN THERAPY OUTPUT. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. A MAGNET WAS APPLIED TO THE DEVICE UNTIL THE FIELD REPRESENTATIVE ARRIVED WITH THE PROGRAMMER. INTERROGATION REVEALED THE SHOCKS WERE DUE TO T-WAVE OVERSENSING, AND THE SMART PASS FEATURE WAS NOT PROGRAMMED ON. IT WAS SUSPECTED THAT AT THE PATIENT'S LAST DEVICE CHECK AT A DIFFERENT FACILITY, AUTOMATIC SETUP WAS NOT PERFORMED SO SMART PASS WAS NOT ENABLED. THE DEVICE WAS MANUALLY REPROGRAMMED FROM THE ALTERNATE VECTOR TO THE SECONDARY VECTOR AND SMART PASS WAS TURNED ON. THE NEXT DAY, AUTOMATIC SETUP WAS PERFORMED. THE DEVICE SELECTED THE SECONDARY VECTOR, A REFERENCE ECG WAS STORED AND IT WAS CONFIRMED SMART PASS WAS ON. THE PATIENT WAS DISCHARGED TO HOME WITH A PLAN TO HAVE A DEVICE CHECK WITH THEIR DEVICE-FOLLOWING HOSPITAL. HOWEVER, THE NEXT DAY THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT FOR CARDIAC ARREST. WHEN THE FIELD REPRESENTATIVE ARRIVED, THE RESUSCITATION EFFORTS HAD BEEN CALLED OFF AND THE PATIENT WAS CONFIRMED DECEASED. THE REPRESENTATIVE INTERROGATED THE DEVICE TO TURN OFF THERAPY AND TO REVIEW THE NEW EPISODES. IT WAS NOTED THE PATIENT BEGAN WITH SHORT RUNS OF NONSUSTAINED VENTRICULAR TACHYCARDIA (VT) THAT PROGRESSED INTO VT AND VENTRICULAR FIBRILLATION (VF). THERE WERE 12 TREATED EPISODES WITH 23 DELIVERED SHOCKS. THE PHYSICIAN REPORTED THE PATIENT HAD BEEN IN REFRACTORY VF AND EIGHT EXTERNAL SHOCKS OF 400 JOULES HAD BEEN DELIVERED IN ADDITION TO THE DEVICE-DELIVERED SHOCKS BUT THE VF COULD NOT BE TERMINATED. BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION ABOUT THIS CASE. AS THE PATIENT DIED AT THE EMERGENCY DEPARTMENT AND BECAME A CORONER'S CASE, THE DEVICE WAS NOT ABLE TO BE EXPLANTED IMMEDIATELY. THE FIELD REPRESENTATIVE WILL WORK WITH THE HOSPITAL TO DETERMINE THE LOCATION OF THE DEVICE AND TO OBTAIN A COPY OF THE CORONER'S REPORT, IF POSSIBLE. INFORMATION ABOUT THE PATIENT'S EVENTS WERE PROVIDED TO THE PATIENT'S PRIMARY CARE PHYSICIAN, WHO SUSPECTED THE PATIENT LIKELY HAD AN ISCHEMIC EVENT LEADING TO THE INAPPROPRIATE SHOCKS. HOWEVER, NO FURTHER INVESTIGATIONS HAD BEEN PERFORMED AFTER THE EPISODES OF INAPPROPRIATE SHOCKS TO DETERMINE OF THERE WAS AN ACTUAL DIMINISHING OF CARDIAC FUNCTION OR IF THE PATIENT HAD DEVELOPED ANY OTHER CONDITIONS SUCH AS ISCHEMIA THAT LED TO THESE EVENTS. TECHNICAL SERVICES REVIEWED AVAILABLE DEVICE DATA AND ADDITIONAL BACKGROUND INFORMATION ABOUT THIS PATIENT AND DEVICE. IT WAS CONFIRMED THE VECTOR HAD BEEN PROGRAMMED TO ALTERNATE SINCE IMPLANT, WITH NO STORED EVENTS AT THE MOST RECENT DEVICE CHECK ON (B)(6) 2018. THE PATIENT WAS ALSO SEEN BY THEIR HEART FAILURE PHYSICIAN ON (B)(6) AND MEDICATION CHANGES WERE MADE; HOWEVER, SPECIFIC DETAILS WERE NOT AVAILABLE. THE PATIENT WAS ALSO REPORTED TO HAVE BEEN ON DIALYSIS BUT TREATMENT DATES WERE NOT KNOWN. A REVIEW OF ELECTROGRAMS FROM THE INAPPROPRIATE SHOCK EPISODES SHOWED THE PATIENT HAD A NOTABLE MORPHOLOGY CHANGE. NO X-RAYS WERE AVAILABLE TO REVIEW THE SYSTEM POSITION, AND IT WAS NOT KNOWN IF THE PATIENT HAD EXPERIENCED ANY PARTICULAR CLINICAL EVENT THAT INITIATED THE MORPHOLOGY CHANGE. THERE WAS CONCERN THE INAPPROPRIATE SHOCKS FURTHER DIMINISHED THE PATIENT'S CARDIAC FUNCTION THUS RESULTING IN THE VF EVENT TWO DAYS LATER WHICH THE PATIENT COULD NOT RECOVER FROM. THE DEVICE WAS NOT EXPECTED TO BE EXPLANTED POST-MORTEM AND WOULD NOT BE RETURNED FOR ANALYSIS. DEVICE DATA FROM THE DATE OF DEATH WAS PROVIDED FOR PATIENT SAFETY COMMITTEE REVIEW. IT WAS NOTED THE SMART PASS FEATURE HAD DISABLED APPROPRIATELY DUE TO THE PATIENT'S ASYSTOLE, AND THE SHOCKS WERE ALL APPROPRIATE FOR VF. ALTHOUGH THE DEVICE FUNCTIONED PROPERLY ON THE DATE OF DEATH, THE COMMITTEE WAS UNABLE TO CONFIRM THAT THE INAPPROPRIATE SHOCKS TWO DAYS PRIOR DID NOT DIMINISH THE PATIENT'S CARDIAC FUNCTION OR CAUSE THE PATIENT TO BECOME PRO-ARRHYTHMIC. THE DEVICE WAS LATER RECEIVED AT BOSTON SCIENTIFIC AND UNDERWENT LABORATORY ANALYSIS.
THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS AVAILABLE.
TECHNICAL SERVICES REVIEWED AVAILABLE DEVICE DATA AND ADDITIONAL BACKGROUND INFORMATION ABOUT THIS PATIENT AND DEVICE. IT WAS CONFIRMED THE VECTOR HAD BEEN PROGRAMMED TO ALTERNATE SINCE IMPLANT, WITH NO STORED EVENTS AT THE MOST RECENT DEVICE CHECK ON (B)(6) 2018. THE PATIENT WAS ALSO SEEN BY THEIR HEART FAILURE PHYSICIAN ON (B)(6) AND MEDICATION CHANGES WERE MADE; HOWEVER, SPECIFIC DETAILS WERE NOT AVAILABLE. THE PATIENT WAS ALSO REPORTED TO HAVE BEEN ON DIALYSIS BUT TREATMENT DATES WERE NOT KNOWN. A REVIEW OF ELECTROGRAMS FROM THE INAPPROPRIATE SHOCK EPISODES SHOWED THE PATIENT HAD A NOTABLE MORPHOLOGY CHANGE. NO X-RAYS WERE AVAILABLE TO REVIEW THE SYSTEM POSITION, AND IT WAS NOT KNOWN IF THE PATIENT HAD EXPERIENCED ANY PARTICULAR CLINICAL EVENT THAT INITIATED THE MORPHOLOGY CHANGE. THERE WAS CONCERN THE INAPPROPRIATE SHOCKS FURTHER DIMINISHED THE PATIENT¿S CARDIAC FUNCTION THUS RESULTING IN THE VF EVENT TWO DAYS LATER WHICH THE PATIENT COULD NOT RECOVER FROM. THE DEVICE WAS NOT EXPECTED TO BE EXPLANTED POST-MORTEM AND WOULD NOT BE RETURNED FOR ANALYSIS. DEVICE DATA FROM THE DATE OF DEATH WAS PROVIDED FOR PATIENT SAFETY COMMITTEE REVIEW. IT WAS NOTED THE SMART PASS FEATURE HAD DISABLED APPROPRIATELY DUE TO THE PATIENT'S ASYSTOLE, AND THE SHOCKS WERE ALL APPROPRIATE FOR VF. ALTHOUGH THE DEVICE FUNCTIONED PROPERLY ON THE DATE OF DEATH, THE COMMITTEE WAS UNABLE TO CONFIRM THAT THE INAPPROPRIATE SHOCKS TWO DAYS PRIOR DID NOT DIMINISH THE PATIENT'S CARDIAC FUNCTION OR CAUSE THE PATIENT TO BECOME PRO-ARRHYTHMIC.
BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION ABOUT THIS CASE. AS THE PATIENT DIED AT THE EMERGENCY DEPARTMENT AND BECAME A CORONER'S CASE, THE DEVICE WAS NOT ABLE TO BE EXPLANTED IMMEDIATELY. THE FIELD REPRESENTATIVE WILL WORK WITH THE HOSPITAL TO DETERMINE THE LOCATION OF THE DEVICE AND TO OBTAIN A COPY OF THE CORONER'S REPORT, IF POSSIBLE. INFORMATION ABOUT THE PATIENT'S EVENTS WERE PROVIDED TO THE PATIENT'S PRIMARY CARE PHYSICIAN, WHO SUSPECTED THE PATIENT LIKELY HAD AN ISCHEMIC EVENT LEADING TO THE INAPPROPRIATE SHOCKS. HOWEVER, NO FURTHER INVESTIGATIONS HAD BEEN PERFORMED AFTER THE EPISODES OF INAPPROPRIATE SHOCKS TO DETERMINE OF THERE WAS AN ACTUAL DIMINISHING OF CARDIAC FUNCTION OR IF THE PATIENT HAD DEVELOPED ANY OTHER CONDITIONS SUCH AS ISCHEMIA THAT LED TO THESE EVENTS.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. A MAGNET WAS APPLIED TO THE DEVICE UNTIL THE FIELD REPRESENTATIVE ARRIVED WITH THE PROGRAMMER. INTERROGATION REVEALED THE SHOCKS WERE DUE TO T-WAVE OVERSENSING, AND THE SMART PASS FEATURE WAS NOT PROGRAMMED ON. IT WAS SUSPECTED THAT AT THE PATIENT'S LAST DEVICE CHECK AT A DIFFERENT FACILITY, AUTOMATIC SETUP WAS NOT PERFORMED SO SMART PASS WAS NOT ENABLED. THE DEVICE WAS MANUALLY REPROGRAMMED FROM THE ALTERNATE VECTOR TO THE SECONDARY VECTOR AND SMART PASS WAS TURNED ON. THE NEXT DAY, AUTOMATIC SETUP WAS PERFORMED. THE DEVICE SELECTED THE SECONDARY VECTOR, A REFERENCE ECG WAS STORED AND IT WAS CONFIRMED SMART PASS WAS ON. THE PATIENT WAS DISCHARGED TO HOME WITH A PLAN TO HAVE A DEVICE CHECK WITH THEIR DEVICE-FOLLOWING HOSPITAL. HOWEVER, THE NEXT DAY THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT FOR CARDIAC ARREST. WHEN THE FIELD REPRESENTATIVE ARRIVED, THE RESUSCITATION EFFORTS HAD BEEN CALLED OFF AND THE PATIENT WAS CONFIRMED DECEASED. THE REPRESENTATIVE INTERROGATED THE DEVICE TO TURN OFF THERAPY AND TO REVIEW THE NEW EPISODES. IT WAS NOTED THE PATIENT BEGAN WITH SHORT RUNS OF NONSUSTAINED VENTRICULAR TACHYCARDIA (VT) THAT PROGRESSED INTO VT AND VENTRICULAR FIBRILLATION (VF). THERE WERE 12 TREATED EPISODES WITH 23 DELIVERED SHOCKS. THE PHYSICIAN REPORTED THE PATIENT HAD BEEN IN REFRACTORY VF AND EIGHT EXTERNAL SHOCKS OF 400 JOULES HAD BEEN DELIVERED IN ADDITION TO THE DEVICE-DELIVERED SHOCKS BUT THE VF COULD NOT BE TERMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311886 | EMBLEM S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | A209 | 102080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| L| R | 3400.| A209.| 3400| A209 |