FDA Adverse Event
Malfunction
Summary report: N
RF ENHANCR II
MDR report key: 2203205
·
Received August 11, 2011
Report
- Report Number
- 2182208-2011-01230
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 4, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LPB
- PMA / PMN Number
- P930029/S021
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B)(4): THE CATHETER WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND, HOWEVER NO INTERNAL OR EXTERNAL PACKAGING WAS RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE OPENING THE CATHETER PACKAGE, THE CUSTOMER NOTICED THAT THE INTERNAL PACKAGING WAS ALREADY OPEN; THEREFORE THE CATHETER WAS NOT STERILE AND UNUSABLE, HOWEVER THE EXTERNAL PACKAGING WAS INTACT. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF ENHANCR II | ABLATION THERAPEUTIC CATHETER | LPB | MEDTRONIC, INC. | 39746534 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |