FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2053235
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04030
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- January 13, 2011
- Report Date
- March 4, 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
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. 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 MULTIPLE INAPPROPRIATE SHOCKS TO THE PATIENT. THE PATIENT'S RHYTHM STARTED IN THE MONITOR ONLY (MO) ZONE AND THEN ACCELERATED INTO THE VT ZONE. TECHNICAL SERVICES DISCUSSED THAT THE DEVICE MAKES A MO ZONE DETECTION DECISION AND AFTER THAT, THE DEVICE IS IN REDETECTION AND THE DETECTION ENHANCEMENTS ARE NOT AVAILABLE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | E102| 0185 |