FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4091697
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04962
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- May 3, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHARGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT PRESENTED IN CLINIC FOR DPT TESTING DUE TO IMPEDANCE MEASUREMENT ANOMALY. UPON REVIEW UNABLE TO DETERMINE THE CAUSE OF ISSUE. THE LEAD WAS UNADDRESSED AND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34040 | RIATA ACTIVE FIXATION | DEFIBRILLATOR LEAD | NVY | ST. JUDE MEDICAL INC., CRMD | 1581/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |