FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 6100672
·
Received November 14, 2016
Report
- Report Number
- 2938836-2016-14185
- Event Type
- Injury
- Date Received
- November 14, 2016
- Date of Event
- October 18, 2016
- Report Date
- October 18, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OFFICE AND EMERGENCY ROOM WITH LETHARGY AND MALAISE. THE PATIENT EXPERIENCED SYMPTOMS OF LIGHTHEADEDNESS. UPON INTERROGATION, LOSS OF CAPTURE WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POST IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 751933 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 7122Q/52 | A000017817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |