FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3223438
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-10336
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 14, 2013
- Report Date
- June 14, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH SHOCKING IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION INDICATED THAT NO INTERVENTION WAS GOING TO BE PERFORMED AT THIS TIME OTHER THAN CLOSE MONITORING. THE DEVICE REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321384 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |