FDA Adverse Event
Malfunction
Summary report: N
ATLAS II VR
MDR report key: 3901016
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12598
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- May 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED COSMETIC ANOMALY WAS CONFIRMED IN THE LABORATORY. VISUAL EXAMINATION OF THE DEVICE SHOWED DISCOLORATION ALONG THE EDGES. IT IS BELIEVED THE DISCOLORATION WAS CAUSED BY THE PROGRAMMED SHOCK VECTOR SETTINGS.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE FOR NORMAL ERI, ANNEALING WAS NOTED ON THE DEVICE, MOST NOTABLY NEAR THE HEADER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380552 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |