FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1050836
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01782
- 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
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
THE REPORTED LOW IMPEDANCE WAS CONFIRMED. THE LEAD WAS RECEIVED IN TWO PARTS. ANALYSIS FOUND INSULATION ABRASIONS AT 13 AND 18CM FROM THE CONNECTOR AND AT 37 AND 40.5CM FROM THE DISTAL ELECTRODE. THE IS-1 DISTAL COIL WAS EXPOSED AT 37 AND 40.5CM FROM THE ELECTRODE. THE DF-1 CABLE INSULATION WAS ABRADED AT 31CM FROM THE DISTAL ELECTRODE AND THE DF-1 CABLE WAS EXPOSED AND MELTED AT 37CM FROM THE DISTAL ELECTRODE.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO LOW HIGH VOLTAGE LEAD IMPEDANCE.
Description of Event or Problem · 1
A DISTRIBUTOR IN (B)(4) REPORTED THAT ELEVEN RT132 INFANT BREATHING CIRCUITS KITS WERE MISSING A PRESSURE LINE CONNECTOR. THIS WAS OBSERVED DURING AN INWARD GOODS INSPECTION, PRIOR TO PT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |