FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS VR
MDR report key: 2984428
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00600
- Event Type
- Malfunction
- Date Received
- February 28, 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 REPORTED NO COMMUNICATION WAS CONFIRMED AND WAS DUE TO A LOW BATTERY VOLTAGE. A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT; NO HIGH CURRENT DRAIN SOURCES WERE OBSERVED. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO BATTERY ANOMALIES WERE DETECTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING REGULAR FOLLOW UP IN (B)(6) 2012, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87852 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |