FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1946089
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20354
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- October 2, 2010
- Report Date
- October 16, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LOCAL AREA REPRESENTATIVE NOTED THAT THE LEAD HAD A HISTORY OF HIGH IMPEDANCES. THERE WAS NO EVIDENCE OF NOISE AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO INTERVENTION WAS PERFORMED AND THE DEVICE REMAINS IN SERVICE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCES.
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 | 65 YR | E102| 1860| 0148 |