FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 4130808
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16140
- Event Type
- Injury
- Date Received
- September 30, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN EMERGENCY ROOM AFTER RECEIVING APPROPRIATE THERAPY. HIGH, OUT OF RANGE PACING LEAD IMPEDANCE WAS OBSERVED. THE LEAD IMPEDANCE HAD BEEN INCREASING FOR THE PAST SEVERAL MONTHS. INCREASED CAPTURE THRESHOLD WAS ALSO NOTED. LEAD FRACTURE DUE TO CLAVICULAR CRUSH WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT CONDITION WAS STABLE AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607469 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |