FDA Adverse Event
Malfunction
Summary report: N
ATLAS II VR
MDR report key: 3220385
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04679
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 27, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MODEL IS V-168 AND WAS REPORTED PREVIOUSLY AS MODEL V-193.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING CAPTURE THRESHOLD, DOUBLE COUNTING WAS OBSERVED. THE PHYSICIAN HAS OPTED TO MAKE NO CHANGES. THE DEVICE AND LEAD REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319850 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | (B)(4) |