FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1050898
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01841
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 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
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. A LEAD TIP STIFFNESS TEST WAS FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
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.
Description of Event or Problem · 1
THE LEAD WAS FOUND TO HAVE PERFORATED THE MYOCARDIUM INTO THE THORAX TISSUE. THE LEAD WAS EXTRACTED BY A THORACOTOMY. A BENT IN THE LEAD TIP WAS OBSERVED. THE LEAD WAS EXPLANTED.
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 | 7002/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |