FDA Adverse Event
Malfunction
Summary report: N
ATLAS II VR
MDR report key: 3080202
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-01031
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- March 4, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
CLARIFICATION OF EVENT: THE PROGRAMMER WAS POWERED OFF AND ON AGAIN, THEN THE DEVICE WAS REINTERROGATED WITH THE SAM RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW UP, THE VIBRATORY PATIENT NOTIFIER WAS TESTED AND THE CLINICIAN NOR THE PATIENT COULD FEEL THE NOTIFIER. THE DEVICE WAS POWERED OFF AND REINTERROGATED WITH THE SAME RESULTS. IT WAS ALSO NOTED THAT THE PATIENT HAD A MRI A YEAR AGO ON THE HEAD AND NECK AREA. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182124 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |