FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION SYSTEM
MDR report key: 1193354
·
Received October 7, 2008
Report
- Report Number
- 3005099803-2008-05118
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 8, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED; 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 WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE FOUR DAYS PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MIDDLE TEMPERATURE COULD NOT BE SENSED AND DROPS OUT INTERMITTENTLY. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION SYSTEM | MEQ | BOSTON SCIENTIFIC CORPORATION | M006880806R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |