FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1073532
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02426
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- March 13, 2008
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ANALYSIS FOUND THAT THE OUTER INSULATION AND IS-1P PROXIMAL CABLE INSULATION WERE ABRADED AT 54CM FROM THE CONNECTOR. THIS ABRASION COULD BE CAUSED BY FRICTION TO ANOTHER DEVICE AND RESULT IN THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY, DUE TO NOISE ON BOTH LEAD CHANNELS. THE LEAD WAS REPLACED.
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. INFLOW CANNULA MALPOSITION SINCE WEIGHT LOSS. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION. CANNULA HAS MOVED LATERALLY. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): NONE. IMPLANT DEVICE TYPE: LVAD.
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 |