FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1010636
·
Received March 10, 2008
Report
- Report Number
- 2017865-2008-01186
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- March 14, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED, CUT AT 12 CM FROM THE CONNECTOR PIN. A LEAD TIP STIFFNESS TEST COULD NOT BE PERFORMED AS THE LEAD TIP WAS NOT RETURNED. WITHOUT THE ENTIRE LEAD, A COMPLETE EVALUATION CANNOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE FIRST DEVICE WAS STUCK ON THE DUCT AND THEY HAD TO PULL IT OFF. THE SECOND DEVICE WAS STUCK ON THE DUCT AND HAD TO BE PULLED OFF THE DUCT. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE, BUT THEY DID NOT KNOW HOW IT WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |