FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 2052878
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04077
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH PAIN AROUND THE DEVICE POCKET. A POCKET EROSION WAS REVEALED, AND A REPOSITIONING PROCEDURE TOOK PLACE. NO FURTHER ADVERSE PATIENT EFFECTS WERE NOTED FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |