FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
MDR report key: 1831153
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03533
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 4, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- 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 AN INAPPROPRIATE THERAPY. HIGH CAPTURE THRESHOLD AND LOW SENSING WERE OBSERVED. PATIENT HAD SEVERAL EPISODES OF NON-SUSTAINED VF EPISODES. ALL THE EPISODES SHOWED A LOW LEVEL NOISE ON THE V-SENSE CHANNEL AS WELL AS SIMILAR NOISE ON THE RV-COIL TO CAN CHANNEL. THE LEAD DID NOT APPEAR TO MOVE SIGNIFICANTLY VIA REVIEW OF THE X-RAY. THE LEAD WAS REPOSITIONED ON (B)(6) 2010. HOWEVER, THE PHYSICIAN DECIDED TO EXPLANT THE LEAD.
Description of Event or Problem · 1
THE LEAD WAS CAPPED.
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 | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |