FDA Adverse Event
Injury
Summary report: N
ATLAS + DR
MDR report key: 1050699
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01656
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 20, 2008
- Report Date
- February 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER AND MANDATORY MEDWATCH FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. IT WAS SUSPECTED THAT THE LEAD MAY NOT HAVE BEEN SECURED IN THE HEADER. OUTPUT DAMAGE WAS SUSPECTED. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS + DR | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |