FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS DR
MDR report key: 1895883
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04770
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 9, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER FEELING A SHOCK. INTERROGATION GAVE AN ALERT MESSAGE OF POSSIBLE OUTPUT CIRCUIT DAMAGE. PATIENT HAD MULTIPLE EPISODES WITH ATP THERAPY. THE CHARGE WAS ABORTED AND THE EPISODE DIAGNOSTIC HAD A MESSAGE OF POSSIBLE OUTPUT CIRCUIT DAMAGE AND ABORTED CHARGE. DATA SUGGESTED A LEAD ANOMALY. BOTH THE ICD AND LEAD WERE REPLACED.
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 | 76 YR | Required Intervention | 7000/60, (B)(4) |