FDA Adverse Event
Malfunction
Summary report: N
PROMOTE RF CRT-D
MDR report key: 3791019
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10415
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- March 24, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF THE INABILITY TO LOOSEN THE SET SCREW WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION NOTED THE RV DF-1 SET SCREW WAS STRIPPED AND RESULTED IN DIFFICULTY LOOSENING THE SET SCREW.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT FOR NORMAL ERI, THE RV LEAD COULD NOT BE REMOVED FROM THE HEADER OF THE DEVICE. A NEW DEVICE AND LEAD WERE IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269097 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | 3213-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |