FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 3920927
·
Received July 8, 2014
Report
- Report Number
- 2938836-2014-13351
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- April 12, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED TO ER DUE TO FEELING A STRANGE SENSATION IN THE CHEST. UPON INTERROGATION OF THE DEVICE, P-WAVE OVERSENSING WAS OBSERVED RESULTING IN THE INHIBITION OF VENTRICULAR PACING. PROGRAMMING CHANGES WERE MADE WHICH RESOLVED THE ISSUE. HOWEVER, THE PATIENT WAS PACEMAKER DEPENDENT, AND WHEN FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS, IT WAS DECIDED TO EXPLANT AND REPLACE THE LEAD. THERE WERE NO COMPLICATIONS FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398383 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |