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 2012-05-24 for EP-4 STINULATOR, 4 CAHNNEL 09-1527-0000 manufactured by St. Jude Medical, Af Division.
[2659725]
It was reported during an ablation procedure, the stimulator was sending improper stimulus to the pt. The physician was using the f5 protocol and wanted to pace at 600 ms, but the stimulus that was sent was 465 ms. The physician checked the settings and stimulated and then saw the values were not what had been programmed. The procedure was stopped with no consequences to the pt. Additional info was requested and is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
[9871682]
We are in the process of evaluating this device. When our investigation is completed, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2012-00014 |
| MDR Report Key | 2590472 |
| Report Source | 01,05,07 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-02 |
| Date of Event | 2012-05-02 |
| Date Mfgr Received | 2012-05-02 |
| Date Added to Maude | 2012-09-18 |
| 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 STINULATOR, 4 CAHNNEL |
| Generic Name | EP RECORDING SYSTEM |
| Product Code | JOQ |
| Date Received | 2012-05-24 |
| Returned To Mfg | 2012-05-18 |
| Model Number | 09-1527-0000 |
| 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 | 2012-05-24 |