FDA Adverse Event
Malfunction
Summary report: N
2124215-2014-09191
MDR report key: 3771438
·
Received April 24, 2014
Report
- Report Number
- 2124215-2014-09191
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 12, 2014
- Report Date
- March 12, 2014
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A TACHYCARDIA DEVICE EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN IN CLINIC. NO ANOMALIES WERE NOTED DURING DEVICE CHECK OR THROUGH X-RAY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES THE OBSERVED MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249232 | LWS | GUIDANT PUERTO RICO BV | TACHY DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |