FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 4133722
·
Received October 1, 2014
Report
- Report Number
- 2938836-2014-16295
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- August 27, 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
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT PRESENTED IN-CLINIC FOR DEVICE CHECK. ABORTED SHOCKS DUE TO LEAD NOISE WERE OBSERVED. LEAD FRACTURE WAS SUSPECTED. LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611082 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |