FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION SYSTEM
MDR report key: 2150332
·
Received August 21, 2008
Report
- Report Number
- 3005099803-2008-02152
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT CONFIRMED UPON RETURN OF DEVICE. RF CONTROL BOARD FAULTY, THEREBY, PRODUCING LOW READINGS DURING BOOT SEQUENCE. THE MODULE WAS REPLACED AND THE CONSOLE PASSED ALL TESTING. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2008, THAT A PROLIEVE THERMODILITATION SYSTEM EXPERIENCED LOW RF POWER DURING TESTING. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION SYSTEM | MEQ | BOSTON SCIENTIFIC CORPORATION | M006880806R0 | CEL3906C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |