ESSENTIO DR
Report
- Report Number
- 2124215-2020-03289
- Event Type
- Injury
- Date Received
- April 3, 2020
- Date of Event
- January 5, 2020
- Report Date
- March 18, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526558924
- PMA / PMN Number
- N970003/S167
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.
THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INFORMATION INDICATES THIS DEVICE WILL BE RETURNED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INFORMATION INDICATES THIS DEVICE WILL BE RETURNED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. THIS PRODUCT HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED AT THIS TIME. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN THE SPRING CONTACT AND THE LEAD TERMINAL.
THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INFORMATION INDICATES THIS DEVICE WILL BE RETURNED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. THIS PRODUCT HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED AT THIS TIME. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN THE SPRING CONTACT AND THE LEAD TERMINAL. THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. DIMENSIONAL ANALYSIS OF THE HEADER WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED, AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. THE ASSOCIATED INVESTIGATION ALSO DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A PRODUCT PERFORMANCE ISSUE OR INADEQUATE LEAD-TO-DEVICE CONNECTION.
IT WAS REPORTED THAT TWO (2) SIGNAL ARTIFACT MONITOR (SAM) EPISODES OCCURRED ON THE SAME DAY DUE TO NOISE OBSERVED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS OF THIS PACEMAKER DEVICE. AS A RESULT, THE MINUTE VENTILATION (MV) FEATURE WAS AUTOMATICALLY DISABLED BY THE DEVICE. IN ADDITION, THERE WAS A LEAD SAFETY SWITCH (LSS) AS WELL AS A HIGH OUT OF RANGE RA PACE IMPEDANCE MEASUREMENT OF 2174 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THE SOURCE NOISE WAS POTENTIALLY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM A POSSIBLE ABLATION OR CAUTERY MEDICAL PROCEDURE. TS PROVIDED GUIDANCE TO THE BOSTON SCIENTIFIC REPRESENTATIVE TO CHECK THE LEADS AND CONSIDER REENABLING THE MV FEATURE. THE DEVICE REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT TWO (2) SIGNAL ARTIFACT MONITOR (SAM) EPISODES OCCURRED ON THE SAME DAY DUE TO NOISE OBSERVED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS OF THIS PACEMAKER DEVICE. AS A RESULT, THE MINUTE VENTILATION (MV) FEATURE WAS AUTOMATICALLY DISABLED BY THE DEVICE. IN ADDITION, THERE WAS A LEAD SAFETY SWITCH (LSS) AS WELL AS A HIGH OUT OF RANGE RA PACE IMPEDANCE MEASUREMENT OF 2174 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THE SOURCE NOISE WAS POTENTIALLY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM A POSSIBLE ABLATION OR CAUTERY MEDICAL PROCEDURE. TS PROVIDED GUIDANCE TO THE BOSTON SCIENTIFIC REPRESENTATIVE TO CHECK THE LEADS AND CONSIDER REENABLING THE MV FEATURE. THE DEVICE REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A SYSTEM REVISION PROCEDURE WAS SCHEDULED APPROXIMATELY 3.5 YEARS LATER. TS REVIEWS OF PACEMAKER DEVICE DATA THE DAY BEFORE THE REVISION PROCEDURE INDICATED THERE WAS A RECENT HIGH OUT OF RANGE RV LEAD PACE IMPEDANCE MEASUREMENT OF 2145 OHMS RESULTING IN AN LSS. THE RV LEAD PACE IMPEDANCE TREND WAS RELATIVELY STABLE PRIOR THIS SUDDEN HIGH OUT OF RANGE MEASUREMENT BUT WITH A BASELINE OF LESS THAN 500 OHMS, WHICH TS NOTED IS LOW OUT OF RANGE FOR THIS LEAD. IT WAS INDICATED THAT THE RA LEAD PACE IMPEDANCE WAS GRADUALLY TRENDING DOWNWARD AND IS IN THE 400 OHM RANGE, WHICH TS AGAIN NOTED WAS LOW OUT OF RANGE FOR THIS LEAD. IN ADDITION, NOISE WAS OBSERVED ON BOTH THE RA AND RV LEADS WHICH WAS OVERSENSED. THE RA LEAD NOISE WAS DESCRIBED BY TS AS LARGE, ERRATIC AND NON-PHYSIOLOGICAL AND THE RV LEAD NOISE WAS DESCRIBED AS VERY FINE, LIKE MYOPOTENTIAL NOISE. BOTH LEADS WERE INDICATED TO BE CURRENTLY PROGRAMMED TO A UNIPOLAR PACING AND BIPOLAR SENSING CONFIGURATION. THE PACEMAKER DEVICE, RA LEAD AND RV LEAD WERE SUBSEQUENTLY EXPLANTED AND REPLACED THE NEXT DAY. IT WAS INDICATED THAT THE PACEMAKER DEVICE WOULD BE RETURNED TO BOSTON SCIENTIFIC, BUT THE RA AND RV LEADS WERE NOTED AS HAVING BEEN DISPOSED OF AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT TWO (2) SIGNAL ARTIFACT MONITOR (SAM) EPISODES OCCURRED ON THE SAME DAY DUE TO NOISE OBSERVED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS OF THIS PACEMAKER DEVICE. AS A RESULT, THE MINUTE VENTILATION (MV) FEATURE WAS AUTOMATICALLY DISABLED BY THE DEVICE. IN ADDITION, THERE WAS A LEAD SAFETY SWITCH (LSS) AS WELL AS A HIGH OUT OF RANGE RA PACE IMPEDANCE MEASUREMENT OF 2174 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THE SOURCE NOISE WAS POTENTIALLY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM A POSSIBLE ABLATION OR CAUTERY MEDICAL PROCEDURE. TS PROVIDED GUIDANCE TO THE BOSTON SCIENTIFIC REPRESENTATIVE TO CHECK THE LEADS AND CONSIDER REENABLING THE MV FEATURE. THE DEVICE REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A SYSTEM REVISION PROCEDURE WAS SCHEDULED APPROXIMATELY 3.5 YEARS LATER. TS REVIEWS OF PACEMAKER DEVICE DATA THE DAY BEFORE THE REVISION PROCEDURE INDICATED THERE WAS A RECENT HIGH OUT OF RANGE RV LEAD PACE IMPEDANCE MEASUREMENT OF 2145 OHMS RESULTING IN AN LSS. THE RV LEAD PACE IMPEDANCE TREND WAS RELATIVELY STABLE PRIOR THIS SUDDEN HIGH OUT OF RANGE MEASUREMENT BUT WITH A BASELINE OF LESS THAN 500 OHMS, WHICH TS NOTED IS LOW OUT OF RANGE FOR THIS LEAD. IT WAS INDICATED THAT THE RA LEAD PACE IMPEDANCE WAS GRADUALLY TRENDING DOWNWARD AND IS IN THE 400 OHM RANGE, WHICH TS AGAIN NOTED WAS LOW OUT OF RANGE FOR THIS LEAD. IN ADDITION, NOISE WAS OBSERVED ON BOTH THE RA AND RV LEADS WHICH WAS OVERSENSED. THE RA LEAD NOISE WAS DESCRIBED BY TS AS LARGE, ERRATIC AND NON-PHYSIOLOGICAL AND THE RV LEAD NOISE WAS DESCRIBED AS VERY FINE, LIKE MYOPOTENTIAL NOISE. BOTH LEADS WERE INDICATED TO BE CURRENTLY PROGRAMMED TO A UNIPOLAR PACING AND BIPOLAR SENSING CONFIGURATION. THE PACEMAKER DEVICE, RA LEAD AND RV LEAD WERE SUBSEQUENTLY EXPLANTED AND REPLACED THE NEXT DAY. IT WAS INDICATED THAT THE PACEMAKER DEVICE WOULD BE RETURNED TO BOSTON SCIENTIFIC, BUT THE RA AND RV LEADS WERE NOTED AS HAVING BEEN DISPOSED OF AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT TWO (2) SIGNAL ARTIFACT MONITOR (SAM) EPISODES OCCURRED ON THE SAME DAY DUE TO NOISE OBSERVED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS OF THIS PACEMAKER DEVICE. AS A RESULT, THE MINUTE VENTILATION (MV) FEATURE WAS AUTOMATICALLY DISABLED BY THE DEVICE. IN ADDITION, THERE WAS A LEAD SAFETY SWITCH (LSS) AS WELL AS A HIGH OUT OF RANGE RA PACE IMPEDANCE MEASUREMENT OF 2174 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THE SOURCE NOISE WAS POTENTIALLY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM A POSSIBLE ABLATION OR CAUTERY MEDICAL PROCEDURE. TS PROVIDED GUIDANCE TO THE BOSTON SCIENTIFIC REPRESENTATIVE TO CHECK THE LEADS AND CONSIDER REENABLING THE MV FEATURE. THE DEVICE REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A SYSTEM REVISION PROCEDURE WAS SCHEDULED APPROXIMATELY 3.5 YEARS LATER. TS REVIEWS OF PACEMAKER DEVICE DATA THE DAY BEFORE THE REVISION PROCEDURE INDICATED THERE WAS A RECENT HIGH OUT OF RANGE RV LEAD PACE IMPEDANCE MEASUREMENT OF 2145 OHMS RESULTING IN AN LSS. THE RV LEAD PACE IMPEDANCE TREND WAS RELATIVELY STABLE PRIOR THIS SUDDEN HIGH OUT OF RANGE MEASUREMENT BUT WITH A BASELINE OF LESS THAN 500 OHMS, WHICH TS NOTED IS LOW OUT OF RANGE FOR THIS LEAD. IT WAS INDICATED THAT THE RA LEAD PACE IMPEDANCE WAS GRADUALLY TRENDING DOWNWARD AND IS IN THE 400 OHM RANGE, WHICH TS AGAIN NOTED WAS LOW OUT OF RANGE FOR THIS LEAD. IN ADDITION, NOISE WAS OBSERVED ON BOTH THE RA AND RV LEADS WHICH WAS OVERSENSED. THE RA LEAD NOISE WAS DESCRIBED BY TS AS LARGE, ERRATIC AND NON-PHYSIOLOGICAL AND THE RV LEAD NOISE WAS DESCRIBED AS VERY FINE, LIKE MYOPOTENTIAL NOISE. BOTH LEADS WERE INDICATED TO BE CURRENTLY PROGRAMMED TO A UNIPOLAR PACING AND BIPOLAR SENSING CONFIGURATION. THE PACEMAKER DEVICE, RA LEAD AND RV LEAD WERE SUBSEQUENTLY EXPLANTED AND REPLACED THE NEXT DAY. IT WAS INDICATED THAT THE PACEMAKER DEVICE WOULD BE RETURNED TO BOSTON SCIENTIFIC, BUT THE RA AND RV LEADS WERE NOTED AS HAVING BEEN DISPOSED OF AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER DEVICE WAS SUBSEQUENTLY RECEIVED AT BOSTON SCIENTIFIC.
IT WAS REPORTED THAT TWO (2) SIGNAL ARTIFACT MONITOR (SAM) EPISODES OCCURRED ON THE SAME DAY DUE TO NOISE OBSERVED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS OF THIS PACEMAKER DEVICE. AS A RESULT, THE MINUTE VENTILATION (MV) FEATURE WAS AUTOMATICALLY DISABLED BY THE DEVICE. IN ADDITION, THERE WAS A LEAD SAFETY SWITCH (LSS) AS WELL AS A HIGH OUT OF RANGE RA PACE IMPEDANCE MEASUREMENT OF 2174 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THE SOURCE NOISE WAS POTENTIALLY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM A POSSIBLE ABLATION OR CAUTERY MEDICAL PROCEDURE. TS PROVIDED GUIDANCE TO THE BOSTON SCIENTIFIC REPRESENTATIVE TO CHECK THE LEADS AND CONSIDER RE-ENABLING THE MV FEATURE. THE DEVICE REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385455 | ESSENTIO DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | L101 | 711744 | 00802526558924 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention| H |