FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 1962328
·
Received January 18, 2011
Report
- Report Number
- 2124215-2011-00847
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 20, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE LOCAL AREA SALES REPRESENTATIVE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ALL AVAILABLE RECORDS INDICATE THAT THIS DEVICE REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT FAINTED. THE PATIENT PERFORMED A PATIENT INITIATED INTERROGATION VIA LATITUDE FOR REVIEW BY THEIR PHYSICIAN. THE PATIENT WAS REFERRED TO THEIR PHYSICIAN FOR INTERROGATION RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Life Threatening | E102| 0185 |