EVERA MRI XT DR SURESCAN
Report
- Report Number
- 9614453-2025-03824
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Date of Event
- September 15, 2025
- Report Date
- November 18, 2025
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: 1999-52 LEAD IMPLANT DATE: (B)(6) 2013 ; 6935-65 LEAD IMPLANT DATE: (B)(6) 2013. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY HAD AN OBSERVATION RELATING TO VT DETECTION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CORRECTION: B5. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY HAD AN OBSERVATION RELATING TO VT DETECTION. ANALYSIS OF THE DEVICE MEMORY HAD AN OBSERVATION RELATING TO SVT DETECTION. THE DEVICE MEMORY INDICATED A VENTRICULAR TACHYARRHYTHMIA THERAPY (ANTITACHYCARDIA PACING). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO THE DEVICE¿S DETECTION BEING ¿FOOLED¿. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..
IT WAS FURTHER REPORTED THAT THE ATRIAL TACHYCARDIA (AT) EPISODE STARTED INSIDE THE SUPRA VENTRICULAR TACHYCARDIA (SVT) AND CONTINUED INSIDE THE INAPPROPRIATE VENTRICULAR TACHYCARDIA (VT) EPISODE. AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED WHICH CHANGED THE ATRIAL TACHYCARDIA INTO A DUAL TACHYCARDIA (AT+VT) WHICH WAS TREATED WITH A SHOCK. IT WAS NOTED THAT THE DEVICE DISCRIMINATOR FEATURE THAT USES PATTERN AND RATE ANALYSIS TO DISCRIMINATE BETWEEN SUPRAVENTRICULAR TACHYCARDIA (SVT) AND TRUE VENTRICULAR TACHYARRHYTHMIAS DID NOT WITHHOLD THERAPY, BECAUSE THE AF/ATRIAL FLUTTER PART OF THE FEATURE IS DESIGNED TO WITHHOLD VENTRICULAR TACHYARRHYTHMIA DETECTION WHEN THE RATIO OF SENSED ATRIAL TO VENTRICULAR EVENTS IS GREATER THAN ONE TO ONE AND THE VENTRICULAR CYCLE LENGTH IS NOT REGULAR, INDICATING IRREGULARLY CONDUCTED ATRIAL FIBRILLATION. THE FEATURE COULD NOT WITHHOLD THOSE KIDS OF RHYTHMS. REPROGRAMMING WAS DONE AND THE PHYSICIAN WILL CONTINUE TO FOLLOW-UP WITH THE PATIENT AND REMOTE MONITORING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE ATRIAL TACHYCARDIA (AT) EPISODE STARTED INSIDE THE SUPRA VENTRICULAR TACHYCARDIA (SVT) AND CONTINUED INSIDE THE INAPPROPRIATE VENTRICULAR TACHYCARDIA (VT) EPISODE. AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED WHICH CHANGED THE ATRIAL TACHYCARDIA INTO A DUAL TACHYCARDIA (AT+VT) WHICH WAS TREATED WITH A SHOCK. IT WAS NOTED THAT THE DEVICE DISCRIMINATOR FEATURE THAT USES PATTERN AND RATE ANALYSIS TO DISCRIMINATE BETWEEN SUPRAVENTRICULAR TACHYCARDIA (SVT) AND TRUE VENTRICULAR TACHYARRHYTHMIAS DID NOT WITHHOLD THERAPY, BECAUSE THE AF/ATRIAL FLUTTER PART OF THE FEATURE IS DESIGNED TO WITHHOLD VENTRICULAR TACHYARRHYTHMIA DETECTION WHEN THE RATIO OF SENSED ATRIAL TO VENTRICULAR EVENTS IS GREATER THAN ONE TO ONE AND THE VENTRICULAR CYCLE LENGTH IS NOT REGULAR, INDICATING IRREGULARLY CONDUCTED ATRIAL FIBRILLATION. THE FEATURE COULD NOT WITHHOLD THOSE KINDS OF RHYTHMS. REPROGRAMMING WAS DONE AND THE PHYSICIAN WILL CONTINUE TO FOLLOW-UP WITH THE PATIENT AND REMOTE MONITORING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2861488 | EVERA MRI XT DR SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC EUROPE SARL | DDMB2D1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| L |