FDA Adverse Event
Malfunction
Summary report: N
ACUITY
MDR report key: 6696695
·
Received July 10, 2017
Report
- Report Number
- 2124215-2017-07581
- Event Type
- Malfunction
- Date Received
- July 10, 2017
- Date of Event
- April 5, 2017
- Report Date
- April 5, 2017
- Manufacturer
- CPI PLANT - ST. PAUL
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WA EMITTING TONES. UPON INTERROGATION, IT WAS NOTED THAT THIS DEVICE AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479530 | ACUITY | IMPLANTABLE LEAD | LWP | CPI PLANT - ST. PAUL | 4674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | 0292| 4674| G158 |