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 2010-04-09 for IRE SINGLE ELECTRODE PROBE NOT REPORTED manufactured by Angiodynamics.
[1578615]
For the fourth and final sequence, the patient experienced an episode of supraventriicular tachycardia (svt). The episode was of moderate intensity and was controlled by drug therapy and resolved in 15-20 min. At that time the fourth and final sequence was initiated and completed without incident. The patient was kept overnight and released to home the following day. The patient's family felt she had deteriorated over the weekend and brought her back 72 hours after the (b) (4) procedure, and she was readmitted. The family had transferred her care from the hospital staff to a private group of gastroenterologists. He suggested that she may have hepatorenal syndrome and proposed inserting a drain into the gallbladder to alleviate the bilirubin issue and dialysis to allow renal function to slowly return to normal. His proposal was not accepted by the outside gastroenterologists as they had suggested the family to consider hospice. The patient was placed on hospice care and died 2 weeks later (21 days post (b) (4)).
Patient Sequence No: 1, Text Type: D, B5
[8532742]
Lot history record review: the catalog number and lot number were not reported. A ship history was conducted and showed the following lots had been shipped to the complainant: catalog number 20400101 / possible lots 081106 and 080911. Review of returned sample: the sample was not returned for evaluation. Conclusion: this complaint is currently under further investigation. A follow up report will be submitted. Frequency has increased but the severity of this event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2010-00017 |
| MDR Report Key | 1658001 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-04-08 |
| Date of Event | 2010-03-13 |
| Date Mfgr Received | 2010-02-24 |
| Date Added to Maude | 2010-04-15 |
| 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 | 3 |
| 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 | 2010-04-09 |
| Catalog Number | NOT REPORTED |
| Lot Number | NOT REPORTED |
| 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. Death; 2. Required No Informationntervention | 2010-04-09 |