FDA Adverse Event
Malfunction
Summary report: N
INTERVENE
MDR report key: 4884304
·
Received July 1, 2015
Report
- Report Number
- 2124215-2015-08373
- Event Type
- Malfunction
- Date Received
- July 1, 2015
- Date of Event
- August 4, 2008
- Report Date
- May 26, 2015
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS LEAD REMAINS IN SERVICE. 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 EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS, INCLUDING OUT OF RANGE MEASUREMENTS. THE PATIENT HAD RECENTLY BEEN SEEN IN CLINIC AND LEAD DIAGNOSTICS WERE GOOD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426080 | INTERVENE | IMPLANTABLE LEAD | LWS | GUIDANT ANGLETON/ST. PAUL | 497-23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | 101-10| 1860| 497-23 |