FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS DR
MDR report key: 1223547
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03611
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 19, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
PATIENT PRESENTED TO THE HOSPITAL AND WAS ADMITTED AFTER RECEIVING SOME HIGH VOLTAGE THERAPIES. INTERROGATION SHOWED NOISE ON THE VENTRICULAR LEAD. IT WAS NOTED THAT THERE WAS AN ISSUE WITH THE DEVICE HEADER. AS SUCH, THE ICD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |