FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1955265
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00101
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 27, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN APPROPRIATE THERAPY WHICH CONVERTED THE PATIENT BACK TO SINUS. HOWEVER, THE MEASURED LEAD IMPEDANCE FOR THE THERAPY WAS HIGH. EGM INDICATED THAT THE HIGH IMPEDANCE WAS A VALID MEASUREMENT FOR A DELIVERED PULSE WIDTHS. THE PHYSICIAN LATER CAPPED THE LEAD. WHEN THE ICD WAS CONNECTED TO THE NEW LEAD, HV LEAD IMPEDANCE WAS STILL HIGH. CONSEQUENTLY, THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | (B)(4) |