FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3053554
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05037
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- October 23, 2012
- Report Date
- March 25, 2013
- 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
A CHEST X-RAY WAS PERFORMED AND THE PATIENT WILL CONTINUE TO BE FOLLOWED VIA REMOTE MONITORING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS SEEN IN CLINIC FOR FURTHER EVALUATION. REVIEW OF DEVICE INFORMATION REVEALED SHOCK IMPEDANCE MEASUREMENTS WERE STABLE AT 50 - 55 OHMS. ALL OTHER LEAD DIAGNOSTICS WERE ACCEPTABLE AND STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154941 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | 0158| E110| 1388TC| A155 |