FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 1223765
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03509
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 18, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WOULD NOT COMMUNICATE DUE TO A DEPLETED BATTERY. THE DEVICE WAS ANALYZED WITH A NEW BATTERY AND FOUND TO BE NORMAL. FURTHER ANALYSIS IDENTIFIED AN INTERNAL ANOMALY WITHIN THE BATTERY. THIS ANOMALY CAUSED THE LOW BATTERY VOLTAGE AND NO COMMUNICATION EXPERIENCED IN THE FIELD.
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 DEVICE COULD NOT BE INTERROGATED. THE LAST KNOWN BATTERY VOLTAGE WAS 2.95V. EKG DID NOT SHOW PACING. THE DECISION WAS MADE TO EXPLANT THE DEVICE.
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 | 82 YR | Required Intervention |