FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 3953284
·
Received July 23, 2014
Report
- Report Number
- 2938836-2014-13642
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- June 23, 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
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT OVERSENSING WAS NOTED SINCE IMPLANT. EGMS WERE REVIEWED AND A LEAD PROBLEM WAS SUSPECTED. THE PATIENT CONTINUES TO BE MONITORED VIA MERLIN.NET TRANSMISSIONS.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES PATIENT PRESENTED TO CLINIC WITH DIZZINESS. THE DEVICE WAS STILL OVERSENSING LEAD NOISE AND INHIBITING PACING. NOISE COULD BE REPRODUCED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432019 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7021/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | CD3257-40 7061987 |