FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 1223767
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03511
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 9, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE FIELD EXPERIENCE OF NO COMMUNICATION WAS CONFIRMED. UPON RECEIPT, NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER. WHEN CUT OPEN, THE BATTERY VOLTAGE WAS FOUND T O BE VERY LOW. WITH ANOTHER BATTERY ATTACHED, THE DEVICE FUNCTION WAS NORMAL. THE DEVICE'S PACE AND SENSE FUNCTIONALITY WAS TESTED AND FOUND TO BE NORMAL. AN EXCESSIVE CURRENT DRAIN WAS CAUSED BY A HYBRID CIRCUIT ANOMALY. THIS RESULTED IN THE BATTERY DEPLETION OBSERVED AND THE FIELD EVENT OF NO COMMUNICATION.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |