FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
MDR report key: 1830524
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03432
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 23, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO DISLODGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |