FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 3210259
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08398
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- November 1, 2011
- Report Date
- April 15, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TO BE ELECTIVELY REPROGRAMMED TO A VENTRICULAR TACHYCARDIA MODE OF MONITOR ONLY. WHEN THE DEVICE WAS INTERROGATED IT WAS FOUND TO HAVE REVERTED TO STORAGE MODE APPROXIMATELY A YEAR AND A HALF EARLIER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED BRADY AND TACHY THERAPY ARE NO LONGER AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310225 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | T165| 4470| 0175 |