FDA Adverse Event
Malfunction
Summary report: N
2124215-2010-18223
MDR report key: 1874985
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-18223
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- September 6, 2010
- Report Date
- September 6, 2010
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AN UNKNOWN TACHY DEVICE AND LEAD WERE EXHIBITING A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED, BUT NO PATIENT INFORMATION WAS PROVIDED. THE SALES REPRESENTATIVE WAS NOT REQUESTED TO INTERROGATE THE DEVICE. THE PHYSICIAN PLANNED TO RESOLVE THE SITUATION WITHOUT THE ASSISTANCE OF BOSTON SCIENTIFIC CRM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LWS | GUIDANT PUERTO RICO BV | TACHY DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |