FDA Adverse Event
Injury
Summary report: N
ATLAS DR
MDR report key: 1073586
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02470
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS CONFIRMED THE REPORTED RESET IN THE LABORATORY. THE REASON FOR THE HARDWARE VVI (HWVVI) RESET WAS A POWER-ON-RESET. THE HWVVI WAS REMOVED AND THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED TEST EQUIPMENT. NO ANOMALY WAS DETECTED AND THE DEVICE MET ALL SPECIFICATIONS. THE RESET COULD NOT BE REPLICATED ON THE BENCH. THE CAUSE WAS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IN A HARDWARE RESET MODE AS SUCH, THE DEVICE WAS EXPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DECEASED. IT WAS NOTED THAT THE LEAD EXHIBITED A MECHANICAL PROBLEM. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-242 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |