FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS DR
MDR report key: 1223289
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03689
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING. THE STRIPS SEEMED LIKE THE PATIENT WAS VERY SICK OR HAD AN ELECTROLYTE IMBALANCE DUE TO THE AMPLITUDE VARIATION AND TACHYCARDIA APPEARANCE. IT WAS NOTED THAT THE PATIENT WAS A DNR STATUS. THE PHYSICIAN DECIDED TO TURN THE ICD HIGH VOLTAGE THERAPY OFF. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |