MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2011-10-07 for EP-4 STIMULATOR, 4 CHANNEL 09-1527-0000 manufactured by St. Jude Medical, Af Division.
[2214843]
The same device was involved in mfr report 2184149-2011-00019 and 2184149-2011-00020. It was reported during an atrial fibrillation (af) procedure, an unexpected stimulus was sent to the pt when the physician chose the electro-cardiogram to stimulate on the pruka system. The physician went into af because the catheter selected on the pruka was located in the left atrium. The physician had wanted to induce af during this procedure, but not at this time it was induced. The af rhythm was treated and the pt recovered. There were no further consequences to the pt. Additional information was requested, but is not available.
Patient Sequence No: 1, Text Type: D, B5
[9427651]
Method - power source testing. Process evaluation (dhr). Simulated use testing. Wear testing. Visual inspection of the return device revealed no anomalies externally. Further inspection inside the unit found evidence of damage from liquid intrusion on several components of the channel # 1 stimulus board. There was also thermal damage in the location of the liquid intrusion on the components of the channel # 1 stimulus board. Residue was also found between the top cover and the chassis. During functional testing, the ep-4 cardiac stimulator passed the post (power on self-test) and communicated with the ep-4 touchscreen pc controller successfully. The self-test and preliminary tests were performed per the system manual. Serial communication functioned properly between the ep-4 cardiac stimulator, ep-4 touchscreen pc controller and ep-workmate recording system. The ep-workmate recording system detected an unexpected stimulus (or spike) when the pacing sites were selected or de-selected while connected to channel 1 of the ep-4 cardiac stimulator. This symptom was intermittent and also caused the dc offset voltages to be out of range. Further testing found the ep-4 cardiac stimulator was producing erratic waveform outputs on stimulus channel 1 due to the damaged components. Both test point 1 and 2 of the stimulus power circuitry were measured to be intermittently out of specification due to the internal damage on ic7 (analog switch) controlling this circuit. Functional testing confirmed all other stimulus channels (channels 2-4) functioned properly. Emergency stimulation and adjustable audio beep tone tested and found to be functioning as designed. Recorded test data was reviewed and confirmed the burst pacing protocol was found to be functioning properly. All pacing protocols (except emergency pacing) are controlled by ep-4 software via ep-4 touchscreen pc controller or ep-4 workmate recording system cpu. Root cause of the failure mode experienced in the field was contributed to erratic stimulus outputs as a result of damage components due to liquid ingress on the channel # 1 stimulus board. Review of the device history records confirmed the device met manufacturing requirements prior to shipment. The root cause classification is consistent with use/user error. The ifu states "the case is not environmentally sealed and none of the components should be immersed in water". While there was no evidence that the device was immersed, there was evidence that internal components of the stimulator were exposed to an unknown liquid, which caused the thermal damage noted in the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2011-00021 |
| MDR Report Key | 2287416 |
| Report Source | 01,05,07 |
| Date Received | 2011-10-07 |
| Date of Report | 2011-09-12 |
| Date Mfgr Received | 2011-09-12 |
| Device Manufacturer Date | 2009-10-15 |
| Date Added to Maude | 2011-10-14 |
| 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 DRIVE |
| 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 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, 4 CHANNEL |
| Generic Name | COMPUTERIZED STIMULATOR DIAGNOSTIC |
| Product Code | JOQ |
| Date Received | 2011-10-07 |
| Returned To Mfg | 2011-09-23 |
| Model Number | 09-1527-0000 |
| 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 | 2011-10-07 |