FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 1830426
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03475
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 4, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE LEAD WAS FOUND TO HAVE DISLODGED. THE PATIENT WAS VERY ACTIVE, NOT ALLOWING FOR THE LEAD TO SET ITSELF IN THE MYOCARDIUM. THE PATIENT HAD RECEIVED A LEAD REPOSITION ONE MONTH PREVIOUS AND THE PHYSICIAN DID NOT WANT TO REPOSITION THE LEAD AGAIN. THE LEAD WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
SMALL METAL "NUB" BROKE OFF IMPACTOR DURING PROCEDURE. PIECE OF METAL RETRIEVED FROM WOUND INTACT. A 3M X 3M PIECE BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121Q/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |