MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-08 for ABLATION CONTROL SYSTEM 11773 manufactured by St. Jude Medical.
[18109721]
A medwatch report was received from the hospital stating the pt had a surgical cardiac ablation using an ultracinch and ultrawand device. Fluoroscopic guidance was used during the procedure, which confirmed the wand and the cinch were correctly placed. A transesophageal echo (tee) had been performed. The pt experienced difficulties swallowing post op and was re admitted. A swallow exam revealed evidence of a localized esophageal perforation. A feeding the tube was placed and the physician indicated they let the esophagus rest. The pt did not require surgery and has fully recovered. The physician stated he did not feel any of the epicor devices contributed to the reported event. The ultrawand and ultracinch (unk reorder and lot) devices are not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[18360020]
None of the components used during the procedure were returned for evaluation. Review of the device history record confirmed this device met manufacturing requirements prior to shipment. The cause for the reported transesophageal perforation remains unk. The physician stated he did not feel any of the epicor devices contributed to the reported event. Date the initial reporter provided the information to the manufacturer: 2/10/2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2010-00001 |
| MDR Report Key | 1626174 |
| Report Source | 05,06 |
| Date Received | 2010-03-08 |
| Date of Report | 2010-02-10 |
| Date of Event | 2009-11-03 |
| Date Facility Aware | 2009-11-03 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2010-03-12 |
| 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 | 240 SANTA ANA COURT |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABLATION CONTROL SYSTEM |
| Generic Name | ABLATION CONTROL SYSTEM |
| Product Code | NTB |
| Date Received | 2010-03-08 |
| Model Number | NA |
| Catalog Number | 11773 |
| Lot 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 |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-03-08 |