FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1873992
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17750
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 3, 2010
- 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
TECHNICAL SERVICES DISCUSSED THERE MAY BE A LOOSE CONNECTION SINCE THE PATIENT RECENTLY UNDERWENT A DEVICE REPLACEMENT PROCEDURE. THE DEVICE AND LEAD WILL CONTINUE TO BE MONITORED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENTS, INCLUDING OUT OF RANGE MEASUREMENTS. THE PACING AND SENSING FUNCTIONS OF THE LEAD WERE GOOD. 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 | 78 YR | E110| 4470| 0185| A155 |