FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 4131633
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14914
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- July 15, 2014
- Report Date
- July 15, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 DEVICE FAILED TO CONVERT AFTER FIVE SHOCKS AND THERAPY WAS EXHAUSTED. THE VENTRICULAR TACHYCARDIA (VT) SPONTANEOUSLY CONVERTED AND THE PATIENT WAS NOT SYMPTOMATIC. DEFIBRILLATION THRESHOLD (DFT) TESTING FOUND THE DEVICE WAS PROGRAMMED IN INITIAL POLARITY, WHEN TESTED IN REVERSED POLARITY THE DEVICE SUCCESSFULLY CONVERTED. REVERSED POLARITY WAS THEN PROGRAMMED ON. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612568 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | T167| 4087| 0185 |