FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2151704
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06026
- Event Type
- Malfunction
- Date Received
- July 6, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THE PHYSICIAN IS AWARE AND PLANS TO MONITOR THE LEAD. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION VIA LATITUDE REMOTE MONITORING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THERE WAS NO NOISE PRESENT ON THE PRESENTING ELECTROGRAM. A REVIEW OF THE PACING IMPEDANCE MEASUREMENTS DID NOT SHOW AN UPWARD TREND, BUT INSTEAD INDICATED THE MEASUREMENTS MOVED UP AND DOWN. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS 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 | 72 YR | E110| 4469| 1831| 0144| 1861| 4244 |