FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3211680
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07869
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 8, 2013
- Report Date
- May 8, 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 AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH PACING LEAD IMPEDANCES GREATER THAN 2,000 OHMS. THIS IS A COMPETITOR LEAD, NO REPORT REQUIRED, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311573 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 6936| 0185| F102 |