FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS HF CRT-D
MDR report key: 1223722
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03536
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- January 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- PMAP030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
THE PATIENT HAD A POCKET WOUND THAT WAS AT FIRST NOTED BY PHYSICIANS TO BE A TAPE WOUND. THE PATIENT LATER WENT TO TO THE EMERGENCY ROOM WHERE IT WAS DETERMINED THAT THE DEVICE HAD ERODED. THE WOUND TESTED POSITIVE FOR STAPHYLO-COCCUS. THE SYSTEM WAS REMOVED. ALTHOUGH THE PATIENT WAS VERY SICK, SHE RECEIVED A NEW DEVICE SIX DAYS POST EXPLANT. SHE LATER EXPIRED, DUE TO FAILING HEALTH FROM DIABETES, CHRONIC KIDNEY DISEASE, AND CHF SECONDARY TO DECOMPENSATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-366 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |