MOMENTUM X4 CRT-D
Report
- Report Number
- 2124215-2024-64610
- Event Type
- Injury
- Date Received
- October 16, 2024
- Date of Event
- September 3, 2024
- Report Date
- April 8, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIK
- UDI-DI
- 00802526589195
- PMA / PMN Number
- P010012/S436
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED PATIENT CODE E060110. B5 FIELD CORRECTION FROM IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE RHYTHM TO VENTRICULAR FIBRILLATION (VF) FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPDATED B5 - IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE VENTRICULAR RHYTHM FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. F10 FIELD CORRECTION FROM F10 PACING PROBLEM TO INACCURATE SYNCHRONIZATION AND UNEXPECTED THERAPEUTIC RESULTS. REPORT NUMBER: 2124215-2024-64610.
B5 FIELD CORRECTION FROM IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE RHYTHM TO VENTRICULAR FIBRILLATION (VF) FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPDATED B5 - IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE VENTRICULAR RHYTHM FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. F10 FIELD CORRECTION FROM F10 PACING PROBLEM TO INACCURATE SYNCHRONIZATION AND UNEXPECTED THERAPEUTIC RESULTS. REPORT NUMBER: 2124215-2024-64610.
IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE RHYTHM TO VENTRICULAR FIBRILLATION (VF) FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE VENTRICULAR RHYTHM FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT A LATITUDE ALERT WAS TRIGGERED DUE TO ANTI-TACHYCARDIA PACING (ATP) TREATMENTS DELIVERED TO THIS PATIENT FOR AN ARRHYTHMIA; HOWEVER, NO ELECTROGRAMS WERE AVAILABLE IN THE LATITUDE DATA. TECHNICAL SERVICES (TS) WERE CONSULTED FOR FURTHER ASSESSMENT. A TS CONSULTANT REVIEWED THE LATITUDE DATA AND NOTED THAT ATP STORAGE MIGHT BE FULL, AS THE PATIENT EXPERIENCED 14 EVENTS LAST MONTH, EACH REQUIRING ONE OR MORE SHOCKS. IT WAS CONFIRMED THAT THE THERAPY WAS APPROPRIATE. THE RHYTHM WAS UNCORRELATED; ATP DID NOT CONVERT THE ARRHYTHMIA, BUT FOR ALL EVENTS EXCEPT ONE, A SUCCESSFUL SINGLE SHOCK WAS DELIVERED. DURING ONE EPISODE, THE SHOCK ACCELERATED THE VENTRICULAR RHYTHM FOR 7 SECONDS BEFORE IT SPONTANEOUSLY RESOLVED. IT WAS EXPLAINED THAT THERE IS A WAY TO FREE UP SPACE TO OBTAIN DEVICE DATA ON THE ELECTROGRAMS (EGMS). IT WAS SUGGESTED THAT THE FIELD CONTACT TS WHEN THE PATIENT IS IN THE CLINIC. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316068 | MOMENTUM X4 CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D | NIK | BOSTON SCIENTIFIC CORPORATION | G138 | 394191 | 00802526589195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Unknown | Required Intervention |