FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1946121
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20262
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- July 29, 2010
- Report Date
- October 14, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT. CURRENT RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED AND IN SERVICE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT WAS IN THE EMERGENCY ROOM AND FOUND TO HAVE A RECORDED EPISODE THAT LASTED LONGER THAN 10 MINUTES. THIS EPISODE WAS REPORTEDLY A CONDUCTED SUPRAVENTRICULAR TACHYCARDIA WHICH WAS DECLARED IN A MONITOR ONLY ZONE, BUT ACCELERATED AFTER ANTI-TACHYCARDIA PACING WAS DELIVERED. A SHOCK THEN SUCCESSFULLY TERMINATED THE EPISODE.
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 | 4136| E110| 0185 |