FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 1950536
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22923
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT COMMENTS WERE MADE ABOUT SIX OR SEVEN COGNIS/TELIGEN DEVICES ERODING THROUGH SEVERAL PATIENTS SKIN. NO INFORMATION WAS OBTAINED. NO INFORMATION IS AVAILABLE REGARDING THE MODEL/SERIAL OF THE DEVICES INVOLVED. AN EFFORT HAS BEEN MADE TO OBTAIN THIS INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |