FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3901255
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12593
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- April 14, 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
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY DURING NORMAL BATTERY CHANGE OUT. NO ELECTRICAL ANOMALIES WERE DETECTED. PATIENT WAS ASYMPTOMATIC. THE LEAD REMAINS IMPLANTED, AND THE PATIENT WILL BE MONITORED WITH ROUTINE FOLLOW-UP. THE PATIENT CONDITION WAS FINE AFTER THE EVENT.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT RECEIVED A VIBRATORY ALERT FOR OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE. CHANGING LEAD IMPEDANCES WERE REPRODUCIBLE WITH ISOMETRICS. CAPTURE ANOMALY WAS ALSO NOTED. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380800 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |