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 2010-04-07 for IRE SINGLE ELECTRODE PROBE 20400102 manufactured by Angiodynamics.
[1576797]
(b) (6) i just learned today that she died. (b) (6) we treated almost 4 weeks ago and who i described in prior emails had markedly improving liver function and renal function. However, she remained ventilator dependent for over 3 weeks for unclear reasons. She had a pre-procedural ecog performance status of 0-1. There was no evidence of ards, or pulmonary edema on cxr. Last friday, her ct showed no pe no ct detectable hepatic pulmonary shunts, and no pulmonary edema. There was no evidence of diaphragmatic injury. There was only a small amount of ascites and pleural effusion. The cause of her pulmonary issues and ventilator dependence are unclear. She had failed several attempts to extubate. There was a discussion of placing a tracheotomy which her children did not support. On monday (b) (6) 2010 she was extubated and transferred to a floor. She passed away later that day. (b) (6) died - 24 days post op which is under the 30 day limit making this a procedural related death. I do not yet know why she was extubated, and why she died. Do not know if she had an autopsy. Will investigate over the next few days and let you know.
Patient Sequence No: 1, Text Type: D, B5
[8665932]
Lot history record review: the lot number was not provided. A ship history showed that the following lots had been shipped in the last 6 months: (b) (4). 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: this complaint is currently under investigation. A copy of the autopsy reported has been requested. A follow up report will be submitted at the end of the investigation. Frequency has increased, but the severity of this event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2010-00016 |
| MDR Report Key | 1655768 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-03-31 |
| Date of Event | 2010-03-22 |
| Date Mfgr Received | 2010-03-29 |
| Date Added to Maude | 2010-04-13 |
| 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 | 2010-04-07 |
| Catalog Number | 20400102 |
| 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 | 2010-04-07 |