FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 1874848
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-18113
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- September 9, 2010
- Report Date
- September 9, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPOSITIONED AND REMAINS IMPLANTED. SHOULD ADDITIOAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR DEFIBRILLATION LEAD DEVELOPED AN INFECTION. ON (B)(6), 2010 A REVISION PROCEDURE WAS PERFORMED. ONCE THE POCKET WAS OPENED, IT WAS OBSERVED THAT THE DEVICE HAD TURNED AND ROTATED ITSELF. THERE WAS NOT A POCKET INFECTION. THE DEVICE WAS REPOSITIONED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |