FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 1874888
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17767
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- September 7, 2010
- Report Date
- April 4, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
DESPITE ATTEMPTS TO OBTAIN FURTHER INFORMATION, NONE COULD BE OBTAINED AND BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THE REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DISPLAYED ELECTIVE REPLACEMENT INDICATORS (ERI). THERE WAS CONCERN THAT THE INCREASING CHARGE TIME RESULTED IN THIS DEVICE REACHING ERI EARLIER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |