FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 4220933
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17397
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- September 15, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF A SESSION RECORD INDICATED THAT A POWER-ON RESET OCCURRED DURING HV THERAPY DELIVERY. THE DEVICE WAS TESTED ON THE BENCH, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE POWER-ON RESET COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED IN-CLINIC AFTER RECEIVING A VIBRATORY ALERT. DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. ATTEMPTS WERE MADE IN RESTORING THE DEVICE BUT WERE UNSUCCESSFUL. DEVICE WAS EXPLANTED AND REPLACED WITH NO COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704103 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |