FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1073178
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02535
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 2, 2008
- 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
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. A LEAD TIP STIFFNESS TEST WAS FOUND TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD PERFORATED. CAPTURE AND SENSING ANOMALIES WERE OBSERVED. NO FURTHER INFORMATION WAS GIVEN.
Description of Event or Problem · 1
THE RN WAS CHANGING THE FLUID REMOVAL RATE ON THE FILTER WHEN THE ALARM READING "MEMORY ERROR" OCCURRED. IT DID NOT ALLOW ME TO ADJUST ANYTHING OR RETRIEVE ANY DATA. I ATTEMPTED TO MANUALLY GIVE THE PT THE BLOOD BACK BUT THE BLOOD WOULD NOT FLOW. THE FILTER CIRCUIT WAS TAKEN DOWN AND A NEW PRISMAFLEX WAS SETUP AND STARTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |