FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR, DF-4 CONNECTOR
MDR report key: 3914538
·
Received July 3, 2014
Report
- Report Number
- 2938836-2014-13071
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- April 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF HIGH PACING LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND AN ANOMALOUS TRANSISTOR WAS NOTED. THE CAUSE OF THE FIELD EVENT WAS DUE TO THE ANOMALOUS TRANSISTOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE IMPLANT THE ATRIAL IMPEDANCE WAS HIGH AND OUT OF RANGE. THE LEAD WAS DISCONNECTED AND INSERTED BACK INTO THE HEADER AND THE IMPEDANCE REMAINED HIGH. THE DEVICE WAS REPLACED WITH NO FURTHER ISSUES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389670 | FORTIFY ASSURA DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2359-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |