FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 2242969
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06646
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- May 23, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS DID NOT CONFIRM THE PREMATURE BATTERY DEPLETION. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED IN THE AUTOMATED SYSTEM; NO ANOMALIES WERE FOUND AND THE DEVICE MET ALL SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED PREMATURE ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-343 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |