FDA Adverse Event
Injury
Summary report: N
ATLAS II HF CRT-D
MDR report key: 1073169
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02526
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 29, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE PATIENT WAS LAST SEEN IN 2008, AND THE BATTERY VOLTAGE WAS 2.55V. A SURFACE ECG SHOWED NO PACING. TECHNICAL SERVICES NOTED THAT THE DEVICE MAY BE FULLY DEPLETED, AND DISCUSSED OTHER OPTIONS TO ESTABLISH COMMUNICATION, WHICH WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II HF CRT-D | INPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-365 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |