FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION SYSTEM
MDR report key: 1203178
·
Received October 17, 2008
Report
- Report Number
- 3005099803-2008-05334
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 18, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SERIAL NUMBER PROVIDED BY THE END USER COULD NOT BE CONFIRMED; THEREFORE, THE DEVICE MFR DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE PROLIEVE THERMODILATATION SYSTEM WILL BE SERVICED ON-SITE. THEREFORE, A FAILURE ANALYSIS IS NOT CURRENTLY AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILITATION SYSTEM EXPERIENCED AN INCORRECT READING WITH ONE TEMPERATE MONITOR THE DAY BEFORE. THERE WAS NO PROCEDURE OR PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION SYSTEM | MEQ | BOSTON SCIENTIFIC CORPORATION | M00688080R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |