FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1073095
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02342
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 10, 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 Location
- IA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS REVEALED AN INSULATION ABRASION AT 50CM FROM THE HELIX, EXPOSING THE PROXIMAL COIL. THE ETFE INSULATION OF ONE OF THE IS-1 PROXIMAL CABLES WAS ABRADED RESULTING IN THE REPORTED NOISE WHEN IN CONTACT WITH THE ICD CAN.
Description of Event or Problem · 1
PATIENT RECEIVED INAPPROPRIATE THERAPIES DUE TO NOISE. LEAD WAS EXPLANTED.
Description of Event or Problem · 1
MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE;PBU CABLE.SPECIFIC COMPONENT(S) INVOLVED: COMPONENT: PBU CABLE.CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTION.INTERVENTION(S): REMINDED PT ABOUT CARE OF EQUIPMENT.IMPLANT DEVICE TYPE: LVAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |