MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-01-12 for EP-4 STIMULATOR, 2 CHANNEL 09-1527-0002 manufactured by St. Jude Medical, Af Division.
[20917346]
It was reported the ep4 stimulator was delivering stimulation incorrectly on the f8 protocol. There was no harm to the pt and the case was able to be finished.
Patient Sequence No: 1, Text Type: D, B5
[21148251]
Method: impedance testing, power source testing. Simulated use testing, process evaluation. Visual inspection of the returned ep-4 stimulator revealed no anomalies. During functional testing, 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. The adjustable audible tone functioned as designed. Output amplitude and impedance tests were performed. The stimulus outputs measured within the acceptance criteria. A pacing test was performed with the workmate system and the stimulus outputs measured within the acceptance criteria. A pacing test was performed with the workmate system and recorded data was reviewed. The unit produced the correct pacing parameters (amplitudes, pulse-widths, and sequential timing). The ep-4 stimulator was allowed to run-in with the f8 (arrhythmia induction) protocol for an add'l 24 hours without errors or board resets recorded. Functional testing indicated the ep-4 stimulator functioned as designed. Visual inspection of the returned ep-4 touchscreen revealed a loose front bezel and a missing i/o cover. No other anomalies were noted. During functional testing, ac power was applied to the touchscreen pc and the power on self test (post) was observed. The touchscreen pc produced one audible beep as an indication of a successful post and successful attempts to load the os (operating system) and ep-4 application. The touchscreen pc fully booted and initiated communication with the ep-4 stimulator successfully. Windows event logs were reviewed and confirmed the touchscreen pc functioned normally. The unit communicated simultaneously with the ep-4 stimulator and the ep workmate system. A communication test was performed with hyper terminals and verified both com1 and com2 did not exhibit delay or errors during the communication test. The system suite diagnostics "stress test" also confirmed the touchscreen pc passed all testing required. The touchscreen pc was connected to the ep-4 stimulator and workmate system and during the test run-in for approx 24 hours without unexpected error recorded. Testing indicated the touchscreen pc functioned as expected. Add'l analysis of the reported event is being conducted. If add'l relevant info becomes available. A supplemental medwatch report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2012-00003 |
| MDR Report Key | 2438237 |
| Report Source | 05,07 |
| Date Received | 2012-01-12 |
| Date of Report | 2011-12-23 |
| Date of Event | 2011-12-23 |
| Date Mfgr Received | 2011-12-23 |
| Device Manufacturer Date | 2009-10-13 |
| Date Added to Maude | 2012-08-06 |
| 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 | 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, 2 CHANNEL |
| Generic Name | COMPUTERIZED STIMULATOR |
| Product Code | JOQ |
| Date Received | 2012-01-12 |
| Returned To Mfg | 2012-01-06 |
| Model Number | 09-1527-0002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-01-12 |