FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS DR
MDR report key: 4760317
·
Received May 8, 2015
Report
- Report Number
- 2938836-2015-04605
- Event Type
- Malfunction
- Date Received
- May 8, 2015
- Date of Event
- March 24, 2015
- 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 Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION DESCRIPTION: THE REPORTED SET SCREW ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS RETURNED WITHOUT THE ARING SEPTUM; DUE TO THE CONDITION OF THE RETURN, THE CAUSE OF THE REPORTED SET SCREW ANOMALY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT ORIGINALLY PRESENTED FOR A DEVICE CHANGE-OUT DUE TO NORMAL ERI.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE ATRIAL SETSCREW COULD NOT BE ACCESSED DUE TO A TISSUE INGROWTH FOUND. THE DEVICE WAS EXPLANTED. THE PATIENT RECEIVED NO ADVERSE CONSEQUENCE FROM THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302496 | ATLAS PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |