FDA Adverse Event
Malfunction
Summary report: N
ATLAS PLUS VR
MDR report key: 4153520
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16494
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 8, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
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 EXHIBITED POST-SENSED T-WAVE OVERSENSING VIA REVIEW OF EGMS. THE ICD WAS REPROGRAMMED. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT AND WILL CONTINUE WITH FOLLOW UPS WITH THE PHYSICIAN.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT EPISODES WERE RETRIEVED. REVIEW OF THE EPISODES REVEALED THAT THERE WERE SOME UNDERSENSED BEATS, SUSPECTED TO BE PVCS. THE BEATS WERE NOT SENSED DUE TO THE SMALL AMPLITUDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632234 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |