FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1944969
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-21353
- Event Type
- Malfunction
- Date Received
- January 3, 2011
- Date of Event
- March 31, 2009
- Report Date
- October 1, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SERVICES DISCUSSED TURNING OFF LATITUDE DAILY MEASUREMENTS. THE AVAILABLE INFORMATION SUGGESTS THIS 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) EXHIBITED HIGH RIGHT ATRIAL PACING IMPEDANCE MEASUREMENTS. A HEALTH CARE PROFESSIONAL REPORTED THEY WERE AWARE OF THE HIGH MEASUREMENTS AND INQUIRED ON TURNING OFF LATITUDE ALERTS. 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 | 59 YR | 1388T| T127| 1821| E110| 0125 |