FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE THERMODILITATION SYSTEM
MDR report key: 1171466
·
Received September 17, 2008
Report
- Report Number
- 3005099803-2008-04665
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 18, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED, THEREFORE, A FAILURE ANALYSIS IS NOT 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 CORPORATION THAT A PROLIEVE THERMODILITATION SYSTEM WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE FOUR DAYS PRIOR. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OF THE RTM (RECTAL TEMPERATURE MONITOR) SENSOR NUMBER THREE WAS TWELVE DEGREES HIGHER THAN THE REST. THE PROCEDURE WAS NOT PERFORMED DUE TO THIS ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE THERMODILITATION SYSTEM | MEQ | BOSTON SCIENTIFIC CORPORATION | M0068808000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |