FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3080092
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00969
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- March 1, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING AN ALERT. INTERROGATION REVEALED AN ALERT FOR OUT OF RANGE HV LEAD IMPEDANCE. REVIEW OF SESSION RECORDS SHOWED AN INCREASE IN HV LEAD IMPEDANCE. THE PHYSICIAN SUSPECTS THE LEAD DISLODGED DUE TO EXCESSIVE CHEST TISSUE. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182573 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | (B)(4), (B)(4) |