FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223065
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03769
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 3, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND THAT THE OUTER INSULATION OF THE IS-1 LEAD WAS ABRADED OPEN FROM 6.4 CM TO 6.8 CM FROM THE CONNECTOR PIN, EXPOSING THE PROXIMAL COIL. THE ABRASION WAS CAUSED BY FRICTION WITH THE ICD CAN. THIS COULD CAUSE THE LOW SENSING OBSERVED IN THE FIELD. THE HV LEAD IMPEDANCE MEASUREMENTS WERE NORMAL.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT EGMS REVEALED NOISE ON THE VENTRICULAR LEAD, RESULTING IN INAPPROPRIATE THERAPY WHEN THE PATIENT LIFTED HIS LEFT ARM.
Description of Event or Problem · 1
LOW SENSING THRESHOLDS, HIGH IMPEDANCE MEASUREMENTS.
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 | 1590/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |