FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 3213225
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09832
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- February 7, 2013
- Report Date
- June 7, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH (OUT OF RANGE) PACING AND SHOCKING IMPEDANCE MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED TO CHECK THIS SYSTEM, WHEN THE POCKET WAS OPENED, THE PHYSICIAN NOTED THE PATIENT WAS DEVELOPING AN INFECTION. THEREFORE, THE ENTIRE SYSTEM WAS EXPLANTD AND THE PATIENT IS BEING TREATED WITH ANTIBIOTICS. A NEW SYSTEM WILL BE IMPLANTED WHEN THE INFECTION IS GONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311977 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| L| R | 5076| E110| 0158 |