FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
MDR report key: 7668180
·
Received July 6, 2018
Report
- Report Number
- 2017865-2018-09887
- Event Type
- Injury
- Date Received
- July 6, 2018
- Date of Event
- March 18, 2010
- Report Date
- July 6, 2018
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVY
- UDI-DI
- 05414734503259
- PMA / PMN Number
- P950022
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED (2017865 000 2010).A FOLLOW UP MEDICAL DEVICE REPORT FOR ANALYSIS WAS ALSO SUBMITTED (2017865 02222 2010).
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTED THAT THE RIGHT VENTRICULAR LEAD WAS ALSO DISLODGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510342 | DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 7170Q/58 | 2872803 | 05414734503259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |