FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3884828
·
Received June 19, 2014
Report
- Report Number
- 2938836-2014-12197
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- April 16, 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
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT FOLLOWING THE LEAD REVISION THE PATIENT DEVELOPED PERICARDITIS RESULTING IN CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT WAS TREATED PHARMACOLOGICALLY AND DISCHARGED FROM THE HOSPITAL. THE LEAD REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FEW DAYS POST IMPLANT, HIGH CAPTURE THRESHOLD WAS NOTED VIA A REMOTE TRANSMISSION. INTERROGATION SHOWED VENTRICULAR LOSS OF CAPTURE AND X-RAY SHOWED POSSIBLE MICRO-DISLODGEMENT. LEAD WAS REPOSITIONED WITHOUT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359999 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |