FDA Adverse Event
Injury
Summary report: N
ATLAS II HF CRT-D
MDR report key: 2242943
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06649
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- June 5, 2011
- Report Date
- July 5, 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 Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED A BATTERY VOLTAGE OF 2.75V, YET THE EOL ALERT HAD BEEN TRIGGERED. THE BATTERY VOLTAGE TREND LOOKED GOOD WITH A SMOOTH RUNDOWN AS EXPECTED. THE PATIENT WAS BROUGHT IN AGAIN THE NEXT DAY AND THE BATTERY VOLTAGE SHOWED LESS THAN 2.20V.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-365 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |