MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-16 for EP-4 STIMULATOR 13901119 manufactured by St. Jude Medical, Af Division.
[17200304]
It was reported during a ventricular tachycardia (vt) study the ep-4 stimulator began pacing independently after successful cardioversion and induced an unintended vt. During the vt study, vt was intentionally induced by the physician. After unsuccessful attempts to overdrive pace the patient out of vt, the patient was successfully cardioverted per the physician. The ep-4 stimulator began pacing on its own after this cardioversion and vt was reportedly re-induced, as evidenced by a different vt morphology than the clinical vt per the physician. The patient was cardioverted again and converted to sinus rhythm. The physician successfully finished the case with no further issues and the patient was sent back to his room in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[17399966]
Visual inspection of the returned device revealed no anomalies. The ep-4 stimulator passed the post (power on self-test) and communicated with the touchscreen pc successfully. The self-test and preliminary tests were performed per the system manual. Serial communication functioned properly between the ep-4 stimulator, touchscreen pc and ep workmate system. Emergency stimulation was also tested and found to be functioning as expected. Adjustable audible tone functioned as designed. Output amplitude and impedance tests were performed. All channel outputs measured within the acceptance criteria. A pacing test was performed with workmate system and the recorded data was reviewed. The unit produced the correct pacing parameters (amplitudes, pulse-widths, and cycle lengths). The ep-4 stimulator was allowed to run-in with the f8 (arrhythmia induction) protocol for several hours without errors or board resets recorded. Additional sense level (external/internal sensing) tests confirmed the stimulator functioned normally. The unit also passed a 2 hours memory test. The ep-4 device can sense from either an external non-isolated high level signal or one of the isolated low level pacing wires. The user should confirm synchronization performance during operation and adjust the synchronization sense level, synchronization delay, setup level % parameter and the setup blanking interval if necessary. An internal trigger signal is generated when the amplitude of the external signal reaches the sense level. When a trigger is received, the stimulus pattern begins after a delay set by the synchronization parameter delay. Dhr review of the device history record confirmed this serial number met manufacturing requirements prior to shipment. The investigation was not able to reproduce reported symptom. The system functioned as intended during evaluation. The root cause classification cannot be determined as the reported event could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2012-00031 |
| MDR Report Key | 2796686 |
| Report Source | 05,07 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-09-19 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-19 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2012-10-22 |
| 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 | 0 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55118 |
| Manufacturer Country | US |
| Manufacturer Postal | 55118 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| 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 | EXTERNAL CARDIAC STIMULATOR |
| Product Code | JOQ |
| Date Received | 2012-10-16 |
| Returned To Mfg | 2012-10-02 |
| Model Number | EP-4 STIMULATOR |
| Catalog Number | 13901119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2012-10-16 |