FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2153629
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06402
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS THAT LED TO THERAPY EXHAUSTION BASED ON DEVICE PROGRAMMING. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS FOR DETECTION ENHANCEMENTS. 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 | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |