FDA Adverse Event
Malfunction
Summary report: N
INTERVENE
MDR report key: 3916794
·
Received July 7, 2014
Report
- Report Number
- 2124215-2014-11203
- Event Type
- Malfunction
- Date Received
- July 7, 2014
- Date of Event
- May 9, 2014
- Report Date
- May 10, 2014
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- 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 THE PATIENT'S HOME MONITORING EQUIPMENT DETECTED AN OUT OF RANGE, HIGH SHOCK IMPEDANCE FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM. ADDITIONAL INFORMATION RECEIVED THAT ALL IS FINE WITH PATIENT AND NO ACTIONS WERE TAKEN. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. VERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393713 | INTERVENE | IMPLANTABLE LEAD | LWS | GUIDANT ANGLETON/ST. PAUL | 497-24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | 438-10| E110| 497-24| 1861| T165| 101-10 |