FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 2163443
·
Received July 15, 2011
Report
- Report Number
- 2124215-2011-07369
- Event Type
- Injury
- Date Received
- July 15, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Additional Manufacturer Narrative · 1
TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO THE PRODUCTS ERODING THROUGH THE PATIENT'S SKIN. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Description of Event or Problem · 1
SUBSEQUENT INFORMATION RECEIVED INDICATED A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS UNSUCCESSFUL DUE TO THE PATIENT'S HIGH DFTS. A LIFE VEST PLANNED TO BE PLACED ON THE PATIENT FOR ONE MONTH UNTIL ANOTHER SYSTEM COULD BE IMPLANTED ON THE LEFT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Life Threatening| R | 0158| A135| 4470| T165 |