FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3220289
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04205
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 7, 2013
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FOLLOWING FIELDS DELETED: B2-REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT DAMAGE (DEVICES)
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT THE DEVICE WAS REPROGRAMMED TO RESOLVE THE INITIAL INAPPROPRIATE THERAPY ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED LATER THAT AT A FOLLOW-UP, SENSING HAD IMPROVED. CAPTURE WAS NORMAL AND STABLE. NO EVENTS WERE REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE FOLLOW-UP, IT WAS OBSERVED THAT THE PATIENT HAD RECEIVED INAPPROPRIATE THERAPY SHOCKS. IT WAS ALSO NOTED THAT THE CAPTURE THRESHOLD HAD INCREASED. THE LEAD IMPEDANCE AND SENSING WERE NORMAL. THE PATIENT WILL BE MONITORED WITH ROUTINE FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321274 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |