MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-03-19 for IRE SINGLE ELECTRODE PROBE 20300101 manufactured by Angiodynamics, Inc..
[19283750]
Pt experienced tachycardia went into atrial fibrillation during the delivery of the ire for the second lesion located in the dome of the liver. The closest active portion of an electrode was less than or equal to 5mm from the pericardium. Anesthesia performed multiple interventions to correct the arrhythmia; beta blocker, lidocaine, cortizome, cardioaversion (20/50/70 joules). Cardioaversion at 70 joules resolved the arrhythmia. Anesthesia checked for electrolyte abnormalities and did not find any. Pt has normal ekg rhythm and recovered from anesthesia fine.
Patient Sequence No: 1, Text Type: D, B5
[19324936]
Lot history record review: the complaint info was forwarded to pronet. Pronet reviewed the possible lot history records and found no variances related to this event were observed. Review of returned sample: the complaint sample is not available for eval. Conclusion: the exact cause of the complaint is unk. Episodes of atrial fibrillation may last a few hours or several days. Most people with atrial fibrillation have some structural abnormalities of the heart related to such conditions as heart disease or high blood pressure. Other factors that may contribute to atrial fibrillation include heart valve disorder, hyperthyroidism or heavy alcohol consumption. This type of complaint will continue to be monitored for trends. No further action required at this time. Frequency has increased but the severity of this event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2010-00010 |
| MDR Report Key | 1639493 |
| Report Source | 05,06,07 |
| Date Received | 2010-03-19 |
| Date of Report | 2010-03-17 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-02-24 |
| Date Added to Maude | 2011-02-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGARET MCGUIRE |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRE SINGLE ELECTRODE PROBE |
| Generic Name | IRE SINGLE ELECTRODE PROBE |
| Product Code | OHJ |
| Date Received | 2010-03-19 |
| Catalog Number | 20300101 |
| Lot Number | 00810709 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-19 |