FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 1073522
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02416
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 28, 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
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE FIELD EXPERIENCE OF PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON THE PROGRAMMED PARAMETERS, A LONGEVITY CALCULATION INDICATED THAT THE DEVICE WAS NOT WITHIN EXPECTED LONGEVITY PERFORMANCE. NO VISUAL ANOMALIES WERE NOTED AND THE DEVICE CURRENT WAS NORMAL. THE DEVICE BATTERY WAS RETURNED TO ITS MANUFACTURER FOR FURTHER ANALYSIS. NO ANOMALIES WERE DETECTED. THE CAUSE OF THE BATTERY DEPLETION COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXCESSIVE BATTERY DEPLETION AND HIGH PACING LEAD IMPEDANCE WERE OBSERVED. IT WAS NOTED THAT THE PATIENT HAD BEEN PREVIOUSLY HIT WITH A SOFTBALL. THE PHYSICIAN IS RUNNING TESTS, AND A DECISION TO EXPLANT WILL NOT BE MADE FOR A COUPLE MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |