FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 2053643
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04659
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 3, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- 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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT REPORTED THAT THE IMPLANT SITE WAS TENDER AND FELT AS IF THE DEVICE WAS COMING OUT. THE SKIN WAS NOT BROKEN AND THERE WAS NO DRAINAGE NOTED. THE DEVICE AND LEAD SYSTEM WAS EXPLANTED DUE TO INFECTION AND A NEW DEVICE AND LEADS SYSTEM WAS IMPLANTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE PROCEDURE.
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 | 47 YR | Life Threatening| R | 4469| 0184| E110 |