FDA Adverse Event
Malfunction
Summary report: N
INTERVENE
MDR report key: 5623118
·
Received May 1, 2016
Report
- Report Number
- 2124215-2016-06419
- Event Type
- Malfunction
- Date Received
- May 1, 2016
- Date of Event
- March 15, 2016
- Report Date
- March 15, 2016
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THERE HAS BEEN NO FURTHER ACTION TAKEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278234 | INTERVENE | IMPLANTABLE LEAD | LWS | GUIDANT ANGLETON/ST. PAUL | 497-23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |