FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2173729
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-11026
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 11, 2011
- Report Date
- June 21, 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
OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED AN INAPPROPRIATE SHOCK. THE PATIENT HAD A MONITOR ONLY VT-1 ZONE IN WHICH THE EPISODE STARTED IN, THEN IT ACCELERATED INTO THE VT ZONE. TECHNICAL SERVICES (TS) DISCUSSED THE BEHAVIOR OF NO DETECTION ENHANCEMENTS WHEN IN REDETECT AND OFFERED PROGRAMMING OPTIONS TO MITIGATE THE ISSUE. 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 | 58 YR | 4470| 0184| T165| E110 |