FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2052596
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04266
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 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. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS DEFIBRILLATOR EXPERIENCED AN ATRIAL ARRHYTHMIA THAT CONDUCTED INTO THE VENTRICLE AND RAISED THE VENTRICULAR RATE TO 150 BPM. AS A RESULT, THE DEVICE DELIVERED SHOCKS UNTIL THERAPY WAS EXHAUSTED. TECHNICAL SERVICES WAS CONTACTED AND DISCUSSED PROGRAMMING OPTIONS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
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 | 58 YR | 0184| E102 |