VIGILANT EL ICD DR
Report
- Report Number
- 2124215-2024-42674
- Event Type
- Injury
- Date Received
- July 10, 2024
- Date of Event
- March 2, 2024
- Report Date
- November 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526587801
- PMA / PMN Number
- P960040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO H6: UPDATED PATIENT CODES FROM E2403/NO CLINICAL SIGN, SYMPTOMS OR CONDITIONS TO E210401/SHOCK FROM PATIENT LEAD(S).
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO H6: UPDATED PATIENT CODES FROM E2403/NO CLINICAL SIGN, SYMPTOMS OR CONDITIONS TO E210401/SHOCK FROM PATIENT LEAD(S).
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUSPECTED TO HAVE DELIVERED ATRIAL PACING THAT INDUCED ATRIAL TACHYCARDIA, AND ELECTROGRAM (EGM) REVIEW WAS REQUESTED. ANTI-TACHYCARDIA PACING (ATP) DID NOT TERMINATE THE RHYTHM, HOWEVER A SUBSEQUENT 41J SHOCK CONVERTED THE RHYTHM. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SEEN SINCE (B)(6) 2023, AND SEVERAL CONSULT REPORTS HAVE BEEN SEEN. ADDITIONALLY, IT WAS SUSPECTED THAT AN INAPPROPRIATE SHOCK WAS DELIVERED IN A RECENT TACHY EPISODE FROM MARCH 2. SINCE THEN, A TOTAL OF SIX SHOCKS AND NINE ATTEMPTS OF ATP HAVE BEEN DELIVERED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUSPECTED TO HAVE DELIVERED ATRIAL PACING THAT INDUCED ATRIAL TACHYCARDIA, AND ELECTROGRAM (EGM) REVIEW WAS REQUESTED. ANTI-TACHYCARDIA PACING (ATP) DID NOT TERMINATE THE RHYTHM, HOWEVER A SUBSEQUENT 41J SHOCK CONVERTED THE RHYTHM. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SEEN SINCE (B)(6) 2023, AND SEVERAL CONSULT REPORTS HAVE BEEN SEEN. ADDITIONALLY, IT WAS SUSPECTED THAT AN INAPPROPRIATE SHOCK WAS DELIVERED IN A RECENT TACHY EPISODE FROM (B)(6). SINCE THEN, A TOTAL OF SIX SHOCKS AND NINE ATTEMPTS OF ATP HAVE BEEN DELIVERED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUSPECTED TO HAVE DELIVERED ATRIAL PACING THAT INDUCED ATRIAL TACHYCARDIA, AND ELECTROGRAM (EGM) REVIEW WAS REQUESTED. ANTI-TACHYCARDIA PACING (ATP) DID NOT TERMINATE THE RHYTHM, HOWEVER A SUBSEQUENT 41J SHOCK CONVERTED THE RHYTHM. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SEEN SINCE SEPTEMBER 2023, AND SEVERAL CONSULT REPORTS HAVE BEEN SEEN. ADDITIONALLY, IT WAS SUSPECTED THAT AN INAPPROPRIATE SHOCK WAS DELIVERED IN A RECENT TACHY EPISODE FROM MARCH 2. SINCE THEN, A TOTAL OF SIX SHOCKS AND NINE ATTEMPTS OF ATP HAVE BEEN DELIVERED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED OVER A YEAR LATER REPORTED THAT THIS ICD STORED AN EPISODE WHERE IT WAS SUSPECTED THAT A BURST OF ANTI-TACHYCARDIA PACING (ATP) AND ONE SHOCK WERE DELIVERED DUE TO AN ATRIAL ARRHYTHMIA. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2040848 | VIGILANT EL ICD DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | D233 | 636696 | 00802526587801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Other |