FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION LEAD
MDR report key: 2243066
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06455
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 26, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS IS TO CORRECT BRAND NAME, COMMON NAME, PRODUCT CODE AND PMA NUMBER.
Additional Manufacturer Narrative · 1
THE LEAD WAS RETURNED IN TWO PIECES. ANALYSIS OF THE RETURNED PORTIONS WAS NORMAL. NO ANOMALY FOUND.
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 RECEIVED AN ALERT FOR OUT OF RANGE IMPEDANCE. HIGH IMPEDANCE WAS OBSERVED. LEAD TO BE REVISED. X-RAY REVEALED NO ABNORMALITY. LEAD REVISION HAS NOT BEEN SCHEDULED TO DATE.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO HIGH, OUT OF RANGE HV LEAD IMPEDANCE.
Description of Event or Problem · 1
NEW INFORMATION STATED THAT THE LEAD WAS EXPLANTED DUE TO HIGH HV LEAD IMPEDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |