FDA Adverse Event
Malfunction
Summary report: N
ATLAS II HF CRT-D
MDR report key: 2902633
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00455
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 7, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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
THE ANOMALY OBSERVED IN THE FIELD WAS CONFIRMED IN THE LABORATORY. THE ROOT CAUSE WAS TRACED TO DAMAGED TRANSISTORS IN THE HYBRID ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-HOSPITAL AFTER RECEIVING SEVERAL SHOCKS. OUTPUT CIRCUIT DAMAGE WAS NOTED. ALERTS FOR LOW POST SHOCK HIGH VOLTAGE LEAD IMPEDANCE AND EXTENDED CHARGE TIME LIMIT WAS ALSO NOTED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8502 | 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 | 72 YR | BIOTRONIK LEAD SD 65/18 (B)(4) |