FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
MDR report key: 1830420
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03477
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- May 5, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- 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
NOISE WAS OBSERVED ON THE ATRIAL CHANNEL ONE DAY POST- IMPLANT. EPISODES CONTINUED RANDOMLY AND WERE NOT REPRODUCIBLE. THE ATRIAL LEAD WAS NOTED TO BE FUNCTIONING PROPERLY. DURING THE SURGICAL PROCEDURE, IT WAS NOTED THAT THE RV LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED WHEN REPOSITIONING WAS UNSUCCESSFUL.
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 | 7121Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | CD3211-36Q, 576191 |