FDA Adverse Event
Injury
Summary report: N
VITALITY
MDR report key: 2052162
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03754
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-0047-08 TO Z-0053-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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
THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED TONES AND REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO CHARGE TIMES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATOR ADVISORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | 0185| 4470| T125 |