MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2011-02-08 for EP-4 STIMULATOR manufactured by St. Jude Medical, Af Division.
[1899682]
It was reported that during an electrophysiology study, the physician was stimulating the atrium with a stimulation train. During the train, a premature atrial contraction (pac) occurred that was not sensed by the stimulator. After the pac, the stimulator delivered a stimulus and induced atrial fibrillation. The pt was cardioverted back into sinus rhythm and is reportedly stable.
Patient Sequence No: 1, Text Type: D, B5
[8842504]
Review of the complaint information revealed the ep4 operated as designed. The ep4 is an electrophysiology stimulator which is designed to be used as a cardiac pacing device during electrophysiology studies. The stimulator will not sense or inhibit pacing during any stimulation train once that train has begun. Since the intent of these stimulation trains is to overdrive the heart's intrinsic rhythm, it would be counterproductive for it to inhibit pacing due to a spontaneous intrinsic event that occurs during the stimulation train. As stated in the ifu for this device, the ep4 stimulator is not designed nor intended to be used as a life sustaining device. It is also not designed nor intended to be used as a demand pacemaker. The device will not return for evaluation as no further investigation is needed. Date report submitted to fda by manufacturer: 02/09/2011. Date the initial reporter provided the information to the manufacturer: (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2011-00001 |
| MDR Report Key | 1990678 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-01-11 |
| Date of Event | 2011-01-11 |
| Date Mfgr Received | 2011-01-11 |
| Date Added to Maude | 2011-02-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SETH KERSTEN |
| Manufacturer Street | ONE ST JUDE MEDICAL DR |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | ONE ST JUDE MEDICAL DR |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP-4 STIMULATOR |
| Generic Name | NONE |
| Product Code | JOQ |
| Date Received | 2011-02-08 |
| Model Number | EP-4 STIMULATOR |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, AF DIVISION |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-08 |