MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-12 for IRE SINGLE PROBE 20401001 manufactured by Angiodynamics.
[1280215]
Bradycardia, hypoxia, asystole added from an email dated january 13, 2010 from gordon single this is an excerpt from dr (b) (6) correspondence: "during a previous rfa under conscious sedation he had episodes of bradycardia that required atropine. The ire electrodes were close to branches of the vagus nerve during the ire so i am assuming we stimulated his vagal nerves which obviously leads to the extreme bradycardia. "
Patient Sequence No: 1, Text Type: D, B5
[8454085]
Lot history record review: the complaint information was forwarded to (b) (4). (b) (4) reviewed the possible lot history records and found no variances related to this event were observed. Review of returned sample: the complaint sample was not returned for evaluation. Conclusion: the exact cause of the complaint is unknown. Bradycardia is a common side effect associated with anesthetic and vagus nerve stimulation. In this reported case the patient had 4+ hours of ga and muscle blockade and the ire electrodes were close to branches of the vagus nerve. This complaint type has been added to the ifu. This ifu is currently in circulation for approval. This type of complaint will continue to be monitored for trend. No further action 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 | 1319211-2010-00006 |
| MDR Report Key | 1601401 |
| Report Source | 05,06 |
| Date Received | 2010-02-12 |
| Date of Report | 2010-02-12 |
| Date of Event | 2010-01-11 |
| Date Mfgr Received | 2010-01-14 |
| Date Added to Maude | 2010-02-24 |
| 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 | 7981215 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRE SINGLE PROBE |
| Generic Name | NANOKNIFE IRREVERSIBLE ELECTROPORATION |
| Product Code | OHJ |
| Date Received | 2010-02-12 |
| Catalog Number | 20401001 |
| Lot Number | 080911 |
| 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 |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-12 |