ACCOLADE MRI EL DR
Report
- Report Number
- 2124215-2022-31395
- Event Type
- Injury
- Date Received
- August 18, 2022
- Date of Event
- June 1, 2022
- Report Date
- November 10, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526559266
- PMA / PMN Number
- P150012/S000
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. 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. 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.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED FLUCTUATING PACE IMPEDANCE MEASUREMENTS OVER THE LAST YEAR AND FOR APPROXIMATELY THE LAST TWO MONTHS, THE PACE IMPEDANCE MEASUREMENTS WERE GREATER THAN 3000 OHMS, WHICH IS HIGH OUT OF RANGE. AS A RESULT, THE ASSOCIATED PACEMAKER DEVICE WAS PROGRAMMED TO VENTRICULAR-ONLY PACE AND SENSE MODE UNTIL A LEAD REVISION COULD BE PERFORMED. THE RA LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED AND REPLACED. DURING THE SURGICAL PROCEDURE, THE NEW RA LEAD WAS CONNECTED TO THE EXISTING PACEMAKER DEVICE, BUT THE RA IMPEDANCE MEASUREMENTS REMAINED OUT OF RANGE. AS A RESULT, THIS PACEMAKER DEVICE WAS EXPLANTED AND REPLACED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED FLUCTUATING PACE IMPEDANCE MEASUREMENTS OVER THE LAST YEAR AND FOR APPROXIMATELY THE LAST TWO MONTHS, THE PACE IMPEDANCE MEASUREMENTS WERE GREATER THAN 3000 OHMS, WHICH IS HIGH OUT OF RANGE. AS A RESULT, THE ASSOCIATED PACEMAKER DEVICE WAS PROGRAMMED TO VENTRICULAR-ONLY PACE AND SENSE MODE UNTIL A LEAD REVISION COULD BE PERFORMED. THE RA LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED AND REPLACED. DURING THE SURGICAL PROCEDURE, THE NEW RA LEAD WAS CONNECTED TO THE EXISTING PACEMAKER DEVICE, BUT THE RA IMPEDANCE MEASUREMENTS REMAINED OUT OF RANGE. AS A RESULT, THIS PACEMAKER DEVICE WAS EXPLANTED AND REPLACED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2848623 | ACCOLADE MRI EL DR | IMPLANTABLE DEVICE | LWP | BOSTON SCIENTIFIC CORPORATION | L331 | 811852 | 00802526559266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Hospitalization| R |