FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 3904172
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-10495
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 2, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- KRG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 DURING A RECENT VISIT WITH THIS PATIENT, THE DEVICE WAS UNABLE TO BE INTERROGATED SUCCESSFULLY. ADDITIONALLY THERE WAS NO TONES HEARD WHEN A MAGNET WAS APPLIED. IT IS BELIEVED THE DEVICE IS NON FUNCTIONAL AT THIS TIME. THE DEVICE REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383396 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | KRG | GUIDANT CRM CLONMEL IRELAND | T165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | 0175| T165| 4473 |