INGEVITY? MRI
Report
- Report Number
- 2124215-2018-12724
- Event Type
- Injury
- Date Received
- July 24, 2018
- Date of Event
- February 14, 2018
- Report Date
- April 28, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526523458
- PMA / PMN Number
- P150012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FOLLOW UP REPORT 4 (ADDITIONAL INFORMATION): THIS REPORT IS BEING SUBMITTED TO UPDATE SECTION H6 CODES. FOLLOW UP REPORT 3 (ADDITIONAL INFORMATION): THIS REPORT IS BEING SUBMITTED TO UPDATE SECTION B5, E1, AND H6 CODES. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
FOLLOW UP REPORT 3 (ADDITIONAL INFORMATION): THIS REPORT IS BEING SUBMITTED TO UPDATE SECTION B5, E1, AND H6 CODES. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
IN THE INTEREST OF CONTINUOUS IMPROVEMENT OF BOSTON SCIENTIFIC INGEVITY PACEMAKER LEADS, A RESEARCH EFFORT WAS STARTED IN (B)(6) 2018 TO EVALUATE THE ELECTRICAL PERFORMANCE OF INGEVITY LEADS MANUFACTURED WITH PLATINUM ANODE AND THE RECENTLY LAUNCH TITANIUM ANODE. ANALYSIS INCLUDED BOTH IMPLANT CHAMBERS (RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, BOTH ACTIVE AND PASSIVE LEAD FIXATION) AND ALL STANDARD ELECTRICAL MEASURES (AUTO PACING THRESHOLD, PACING IMPEDANCE, AND SENSE AMPLITUDE). STORED LATITUDE DATA WAS REVIEWED BY BOSTON SCIENTIFIC RESEARCH AND DEVELOPMENT. IDENTIFICATION OF NUMERIC RA/RV PACING IMPEDANCE MEASUREMENTS THAT ARE OUT-OF-RANGE (LESS THAN OR EQUAL TO 200 OHMS, GREATER THAN OR EQUAL TO 2000 OHMS) OR NON-NUMERIC RA/RV PACING IMPEDANCE VALUES (SATURATED, LESS THAN MINIMUM) WILL BE REPORTED TO EVENT ANALYSIS AS POTENTIAL PRODUCT EXPERIENCES. BASED ON REVIEW OF STORED LATITUDE DATA FOR THIS INGEVITY LEAD MODEL NUMBER/SERIAL NUMBER, THE FOLLOWING CLINICAL OBSERVATION WAS IDENTIFIED: SATURATED RA PACING IMPEDANCE VALUE. THE AVAILABLE INFORMATION SUGGESTS THAT THIS LEAD REMAINS IN-SERVICE. IT WAS REPORTED THAT THIS BOSTON SCIENTIFIC SALES REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES IN (B)(6) 2019 TO REPORT THAT THIS IMPLANTABLE RIGHT ATRIAL PACEMAKER LEAD WAS EXHIBITING PACING IMPEDANCE THAT WAS GREATER THAN 3000 OHMS ASSOCIATED WITH NO CAPTURE AT MAXIMUM OUTPUT AND RANDOM ELECTROGRAM NOISE. THE OBSERVATION WAS REPRODUCIBLE WITH POCKET MANIPULATION. THERE WAS NORMAL SENSING OF THE PATIENT INTRINSIC RHYTHM. AN X-RAY SHOWED NO GROSS ABNORMALITIES. THE PHYSICIAN FELT THAT THERE WAS NO REASONABLE EVIDENCE OF LEAD FRACTURE. THERE WAS NO CHANGES TO THE DEVICE PROGRAMMED SETTINGS AND THERE WERE NO PATIENT SYMPTOMS. ADDITIONAL INFORMATION INDICATED THAT THIS RA LEAD HAD A FRACTURE. AS A RESULT, THE PATIENT UNDERWENT A LASER EXTRACTION PROCEDURE, PART OF THIS RA LEAD WAS EXPLANTED, AND THE REST WAS LEFT IN THE RIGHT ATRIUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IN THE INTEREST OF CONTINUOUS IMPROVEMENT OF BOSTON SCIENTIFIC INGEVITY PACEMAKER LEADS, A RESEARCH EFFORT WAS STARTED IN (B)(6) 2018 TO EVALUATE THE ELECTRICAL PERFORMANCE OF INGEVITY LEADS MANUFACTURED WITH PLATINUM ANODE AND THE RECENTLY LAUNCH TITANIUM ANODE. ANALYSIS INCLUDED BOTH IMPLANT CHAMBERS (RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, BOTH ACTIVE AND PASSIVE LEAD FIXATION) AND ALL STANDARD ELECTRICAL MEASURES (AUTO PACING THRESHOLD, PACING IMPEDANCE, AND SENSE AMPLITUDE). STORED LATITUDE DATA WAS REVIEWED BY BOSTON SCIENTIFIC RESEARCH AND DEVELOPMENT. IDENTIFICATION OF NUMERIC RA/RV PACING IMPEDANCE MEASUREMENTS THAT ARE OUT-OF-RANGE (LESS THAN OR EQUAL TO 200 OHMS, GREATER THAN OR EQUAL TO 2000 OHMS) OR NON-NUMERIC RA/RV PACING IMPEDANCE VALUES (SATURATED, LESS THAN MINIMUM) WILL BE REPORTED TO EVENT ANALYSIS AS POTENTIAL PRODUCT EXPERIENCES. BASED ON REVIEW OF STORED LATITUDE DATA FOR THIS INGEVITY LEAD MODEL NUMBER/SERIAL NUMBER, THE FOLLOWING CLINICAL OBSERVATION WAS IDENTIFIED: SATURATED RA PACING IMPEDANCE VALUE. THE AVAILABLE INFORMATION SUGGESTS THAT THIS LEAD REMAINS IN-SERVICE. IT WAS REPORTED THAT THIS BOSTON SCIENTIFIC SALES REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES IN (B)(6) 2019 TO REPORT THAT THIS IMPLANTABLE RIGHT ATRIAL PACEMAKER LEAD WAS EXHIBITING PACING IMPEDANCE THAT WAS GREATER THAN 3000 OHMS ASSOCIATED WITH NO CAPTURE AT MAXIMUM OUTPUT AND RANDOM ELECTROGRAM NOISE. THE OBSERVATION WAS REPRODUCIBLE WITH POCKET MANIPULATION. THERE WAS NORMAL SENSING OF THE PATIENT INTRINSIC RHYTHM. AN X-RAY SHOWED NO GROSS ABNORMALITIES. THE PHYSICIAN FELT THAT THERE WAS NO REASONABLE EVIDENCE OF LEAD FRACTURE. THERE WAS NO CHANGES TO THE DEVICE PROGRAMMED SETTINGS AND THERE WERE NO PATIENT SYMPTOMS. ADDITIONAL INFORMATION INDICATED THAT THIS RA LEAD HAD A FRACTURE. AS A RESULT, THE PATIENT UNDERWENT A LASER EXTRACTION PROCEDURE, PART OF THIS RA LEAD WAS EXPLANTED, AND THE REST WAS LEFT IN THE RIGHT ATRIUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
THE AVAILABLE INFORMATION SUGGESTS THAT THIS LEAD REMAINS IN-SERVICE. THE INVESTIGATION OF THIS EVENT IS ON-GOING IN AN EFFORT TO OBTAIN ADDITIONAL INFORMATION.
DESPTE MULTIPLE ATTEMPTS, NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE LOCAL REPERSENTATIVE.
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
IN THE INTEREST OF CONTINUOUS IMPROVEMENT OF BOSTON SCIENTIFIC¿S INGEVITY PACEMAKER LEADS, A RESEARCH EFFORT WAS STARTED TO EVALUATE THE ELECTRICAL PERFORMANCE OF INGEVITY LEADS MANUFACTURED WITH PLATINUM ANODE AND THE RECENTLY LAUNCH TITANIUM ANODE. ANALYSIS INCLUDED BOTH IMPLANT CHAMBERS (RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, BOTH ACTIVE AND PASSIVE LEAD FIXATION) AND ALL STANDARD ELECTRICAL MEASURES (AUTO PACING THRESHOLD, PACING IMPEDANCE, AND SENSE AMPLITUDE). STORED LATITUDE DATA WAS REVIEWED BY BOSTON SCIENTIFIC¿S RESEARCH AND DEVELOPMENT. IDENTIFICATION OF NUMERIC RA/RV PACING IMPEDANCE MEASUREMENTS THAT ARE OUT-OF-RANGE (LESS THAN OR=200 OHMS, GREATER THAN OR =2000 OHMS) OR NON-NUMERIC RA/RV PACING IMPEDANCE VALUES (SATURATED, LESS THAN MINIMUM) WILL BE REPORTED TO EVENT ANALYSIS AS POTENTIAL PRODUCT EXPERIENCES. BASED ON REVIEW OF STORED LATITUDE DATA FOR THIS INGEVITY LEAD MODEL NUMBER/SERIAL NUMBER, THE FOLLOWING CLINICAL OBSERVATION WAS IDENTIFIED: SATURATED RA PACING IMPEDANCE VALUE.
IN THE INTEREST OF CONTINUOUS IMPROVEMENT OF BOSTON SCIENTIFIC INGEVITY PACEMAKER LEADS, A RESEARCH EFFORT WAS STARTED IN JULY 2018 TO EVALUATE THE ELECTRICAL PERFORMANCE OF INGEVITY LEADS MANUFACTURED WITH PLATINUM ANODE AND THE RECENTLY LAUNCH TITANIUM ANODE. ANALYSIS INCLUDED BOTH IMPLANT CHAMBERS (RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, BOTH ACTIVE AND PASSIVE LEAD FIXATION) AND ALL STANDARD ELECTRICAL MEASURES (AUTO PACING THRESHOLD, PACING IMPEDANCE, AND SENSE AMPLITUDE). STORED LATITUDE DATA WAS REVIEWED BY BOSTON SCIENTIFIC RESEARCH AND DEVELOPMENT. IDENTIFICATION OF NUMERIC RA/RV PACING IMPEDANCE MEASUREMENTS THAT ARE OUT-OF-RANGE (LESS THAN OR EQUAL TO 200 OHMS, GREATER THAN OR EQUAL TO 2000 OHMS) OR NON-NUMERIC RA/RV PACING IMPEDANCE VALUES (SATURATED, LESS THAN MINIMUM) WILL BE REPORTED TO EVENT ANALYSIS AS POTENTIAL PRODUCT EXPERIENCES. BASED ON REVIEW OF STORED LATITUDE DATA FOR THIS INGEVITY LEAD MODEL NUMBER/SERIAL NUMBER, THE FOLLOWING CLINICAL OBSERVATION WAS IDENTIFIED: SATURATED RA PACING IMPEDANCE VALUE. THE AVAILABLE INFORMATION SUGGESTS THAT THIS LEAD REMAINS IN-SERVICE. IT WAS REPORTED THAT THIS BOSTON SCIENTIFIC SALES REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES IN JANUARY 2019 TO REPORT THAT THIS IMPLANTABLE RIGHT ATRIAL PACEMAKER LEAD WAS EXHIBITING PACING IMPEDANCE THAT WAS GREATER THAN 3000 OHMS ASSOCIATED WITH NO CAPTURE AT MAXIMUM OUTPUT AND RANDOM ELECTROGRAM NOISE. THE OBSERVATION WAS REPRODUCIBLE WITH POCKET MANIPULATION. THERE WAS NORMAL SENSING OF THE PATIENT INTRINSIC RHYTHM. AN X-RAY SHOWED NO GROSS ABNORMALITIES. THE PHYSICIAN FELT THAT THERE WAS NO REASONABLE EVIDENCE OF LEAD FRACTURE. THERE WAS NO CHANGES TO THE DEVICE PROGRAMMED SETTINGS AND THERE WERE NO PATIENT SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284687 | INGEVITY? MRI | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7741 | 816620 | 00802526523458 |
| 284688 | INGEVITY? MRI | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7741 | 816620 | 00802526523458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Hospitalization| R | 0296.| 4677.| 7741.| G447.| 0296| 4677| 7741| G447 |