FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 2161630
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-06995
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT INTERROGATION OF THIS DEVICE A CHECK RIGHT ATRIAL (RA) LEAD SCREEN SHOWED UP. THE RA LEAD AMPLITUDE HAS INCREASED SINCE IMPLANT, THE THRESHOLDS IN THE ATRIUM ARE BEING OVERSENSED IN THE VENTRICLE CAUSING PACING INHIBITION. AS A RESULT THE PROGRAMMED SETTINGS FOR SENSING WILL BE OPTIMIZED WHICH WILL ALLEVIATE THESE ISSUES.
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 | 84 YR | E110| A155| 4245| 1831| 0145| 4244 |